NUVO heißer Biotech-Play! - 500 Beiträge pro Seite

[SharpRatio]

NUVO RESEARCH INC.
Wkn: A0HHKB
Kanada/Deutschland


Nuvo muss mit der US-Gesundheitsbehörde FDA noch Details mit seinem Medikament (gg. Gelenkversteifung) klären. Wer den Vertrieb anschließend übernehmen könnte ist unklar. Es werden Konzerne wie Johnson&Johnson oder Novartis genannt. (So ein aktuelles Börsenmagazin unter "Börsengeflüster"). So sei die Wahrscheinlichkeit hoch, dass Nuvo noch im Januar einen Partner präsentieren wird, heißt es weiter. Ein positiver Grundbescheid seitens FDA sei erfolgt.

Aktuell ist der Titel auf den der Charttechnik her interessant. Aktuell bildet der Titel ein schönes "W" aus.

Dies ist keine Aufforderung zum Kauf oder Verkauf. Aktien können steigen oder fallen. In einigen Fällen ist auch ein Totalverlust möglich. Alle Angaben ohne Gewähr.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Ich wollte den Titel erstmal beobachten. Nachdem jetzt das Volumen aufdreht und nach Norden zieht bin ich mal spekulativ rein. Grundsätzlich halte ich mich von Biotechs fern. Hier mach ich mal ne Ausnahme. Zumindest eine Trading-Chance halte ich für möglich.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Nachdem der Titel heute gut nach Nordne läuft, sollte auch der MACD am Montag positiv sein. Aber sicher weiss mans erst zum Handelsende. Zum jetzigen Zeitpunkt schaut alles nach einem positiven Close aus.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Zumindest ist der Titel mal eine Beobachtung wert. (Vertriebspartner, FDA News etc).

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Aktuell 2,9 Mio. Handel, Geld 0,66 Brief 0,67. Mal sehen.

[Rosenberger]

Antwort auf Beitrag Nr.: 26.866.545 von SharpRatio am 12.01.07 18:19:31

450k auf der ASK seite

da liegt erstmal ein stein im weg.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.653 von Rosenberger am 12.01.07 18:22:44

0,65 / 0,66 in Kanada. Mal sehen. Ich denke nicht dass es ein Fake war bei dem Volumen. Aber sicher weiß mans immer erst zum Schluss

[URANI]

Die Frage ist nur ob der Stein bebusst plaziert wurde....

[Rosenberger]

Antwort auf Beitrag Nr.: 26.866.707 von URANI am 12.01.07 18:24:41

naja. und die 698k bei .68? die dundees dieser welt wollen sicherlich noch ihre optionen ziehen und zu gold machen. daher wird das so schnell nichts werden.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.780 von Rosenberger am 12.01.07 18:27:33

Abwarten. Ein "W" wird sich heute herausbilden. Der Chart schaut lecker aus und es stehen ein paar News an.

[Rosenberger]

Antwort auf Beitrag Nr.: 26.868.114 von SharpRatio am 12.01.07 19:20:53

63 zu 64... da hat heute früh wohl einer vergessen zu limitieren

[Rosenberger]

Antwort auf Beitrag Nr.: 26.866.691 von SharpRatio am 12.01.07 18:23:57

übrigens... da ist bei .49 can dollar noch ein GAP offen...

[Rosenberger]

Antwort auf Beitrag Nr.: 26.868.291 von Rosenberger am 12.01.07 19:27:41

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.373 von Rosenberger am 12.01.07 19:30:37

umso besser!

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.373 von Rosenberger am 12.01.07 19:30:37

Nach den Handelsstunden wird die "W" Formation immer wahrscheinlicher.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.291 von Rosenberger am 12.01.07 19:27:41

übrigens... da ist bei .49 can dollar noch ein GAP offen...

Dazu geb ich jetzt keinen Kommentar mehr ab. Das Thema ist in der Vergangenheit mehr als X-mal diskutiert worden.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.373 von Rosenberger am 12.01.07 19:30:37

Gerade hat einer 800 k ins Geld verkauft. Heftig. Somit hat er den 64 er Geldkurs vernichtet.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.373 von Rosenberger am 12.01.07 19:30:37

Somit werden wir kein Close bei 0,65 sehen. Tippe auf 63 oder 64 er Close.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.868.373 von Rosenberger am 12.01.07 19:30:37

Ok, Close von 0,63. Gute Nacht!

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Pinnacle Digest: Lead Drug and Overall Future Reviewed
1/16/2007
Jan 16, 2007 (M2 PRESSWIRE via COMTEX News Network) --

Nuvo Research Inc.'s (TSX:NRI) shareholders experienced a 1.59% rise in share value, coupled by 1,087,061 shares trading hands. They announced recently that they have received an approvable letter from the U.S. Food and Drug Administration (FDA) for Pennsaid, a topical non-steroidal anti-inflammatory developed by Nuvo for use as a treatment of osteoarthritis (OA) of the knee. Pennsaid is based on Nuvo's skin-penetrating technology that allows diclofenac to be delivered directly to the knee via topical application to the surface of the skin thus minimizing systemic side effects often associated with oral therapies. PinnacleDigest is very interested in this new development as has begun reviewing Nuvo Research and more specifically their course of action in respect to Pennsaid.

In the letter the FDA noted that Pennsaid is approvable subject to Nuvo satisfying a few conditions. The company has stated that they plan to meet with the FDA in early 2007 to discuss the letter. PinnacleDigest will be awaiting further development and news regarding this meeting.

PinnacleDigest has reason to believe that this company is headed in the right direction with their focus and action. The pharacuetical world is moving at a quick pace and only the most practical and in demand products will find their share of the market. PinnacleDigest believes companies within this sector are tied to the overall movement of the industry. We closely evaluate the healthcare sector and its sentiment before reviewing a company such as Nuvo Research Inc.At PinnacleDigest we offer a unique approach to investing and are constantly striving to meet our client's needs. To continue with this review and find out exactly what we have to offer come explore us at www.pinnacledigest.com.

Acquisitions and product alliances of biotechnology companies have been rising drastically of late, and this is evident when reviewing the figures of last year. Bigger drug makers can foresee a future in which the environment and demand for drugs is a very positive one over the coming 25 years. These larger companies are buying up smaller companies, attempting to reach out to and control more of the market. The rate of these types of acquisitions and alliances rose an astonishing 32% in the year of 2006. This needs to be acknowledged and reviewed heading into the New Year.

In recapping 2006 and looking to the future, biotechnology companies raised $20 billion in partnership deals last year. That is up from $17 billion in 2005, according to Burrill. That increase doesn't seem overly amazing, but a growth of that size has not occurred in recent years.

Our members would remember our evaluation of Pfizer and its devastating losses following its discontinued development of the drug hailed to replace Lipitor. As expected the market overreacted to the news, dropping more than $3 over the 4th and 5th of December. Since then Pfizer's share value has stabilized increasing to $26.64 on the NYSE. They are poised to possibly lose up to half of their $51 billion in 2005 sales as a result of competition from generic drug makers. It is very simple to understand that as their patents expire, companies will be jumping at the chance to produce generic drugs and get a piece of the market. Pfizer has entered at least six research partnerships since November. As well as conducted two transactions which was disclosed and totaled a combined $450 million. These larger companies need to ensure growth, and if not from within it has to come in the form of smaller companies with drugs on the move.

Let's turn back to Nuvo Research Inc. and their quickly developing product in Pennsaid. The Arthritis Foundation estimates that more than 21 million Americans suffer from osteoarthritis. Pennsaid would be the first topical NSAID product approved in the United States where the osteoarthritis pain relief market is estimated at $4 billion US. Those numbers speak for themselves, however they need to be kept in check and not depended on for success.

Let's hear from Dr. Henrich Guntermann, Nuvo's President and CEO on his thoughts towards Pennsaid and its development. "This approvable letter is a great achievement for our Company and a step forward to the commercialization of Pennsaid in the U.S." He went on to note that, "We plan to work closely with the FDA to resolve these outstanding matters required to obtain final approval and expect to provide further information following our meeting with the FDA." PinnacleDigest will be watching this company over the coming months, and reviewing any major movements that may occur. To continue with our review of Nuvo Research Inc. come explore our investor based community at www.pinnacledigest.com.

To continue with this report as well as other related articles, please visit www.pinnacledigest.com for a complimentary membership. It should be stated that our membership requires no credit card information, nor any commitment to our service. If you would like to contact us please write to [e-mail].

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[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

So wie ich gehört hab, geht es um Warnhinweise auf dem Medikamt. Aber hier müssen wir auf News warten.

The company has stated that they plan to meet with the FDA in early 2007 to discuss the letter.

[Stammzelle]

Antwort auf Beitrag Nr.: 26.974.864 von SharpRatio am 17.01.07 08:32:44

Hi SharpRatio,

würdest du mir verraten, woher du diese Info hast? Wäre nett, wenn du etwas dazu sagen könntest.

Hat sich eigentlich Global Biotech Investor, die NRI im Dezember ins Musterdepot aufgenommen, hatten, zur Situation geäußert?




Gruß, Stammzelle.

[SharpRatio]

Antwort auf Beitrag Nr.: 26.975.159 von Stammzelle am 17.01.07 08:51:03

Hei! Nein, es gibt nichts amtliches, weil die Gespräche noch laufen. Wir müssen warten. Aktuell starkes Geldsize 0.6 (2220) / 0.61 (375)

[SharpRatio]

Antwort auf Beitrag Nr.: 26.866.251 von SharpRatio am 12.01.07 18:10:17

Nächster Widerstand 0,60 CAD. Dannach ist der nächste Widerstand das Window. Fallen wir unter 0,60 CAD muss ich vorerst kurzfristig mal aussteigen.

[meislo]

Die Entwicklung unseres Musterdepots ist nach wie vor sehr erfreulich. Unsere erste Aufnahme, die Aktien des
kanadischen Biotech-Unternehmens Nuvo Research, sollte bis Mitte Februar in ruhigeres Fahrwasser übergehen.
Das von uns erwartete „approval“ für das Medikament Pennsaid wurde durch die FDA am 28.12.2006 erteilt. Nun
gibt es weitere Gespräche mit der FDA, während parallel dazu die Verhandlungen mit möglichen Vertriebspartnern
laufen. Nach unseren Informationen wird sich das Management von Nuvo Research Ende Januar mit Vertretern der
FDA treffen, um die finalen Nachbesserungen für die endgültige Freigabe zum amerikanischen Markt zu besprechen.
Nach dem Gespräch wird es sicherlich noch einmal etwa 30 Kalendertage dauern, bis mit einer Antwort von Seiten
der Food and Drug Administration gerechnet werden kann. Wir gehen davon aus, dass Nuvo Research die
endgültige Freigabe erhalten wird und diese Ende Februar zusammen mit dem Vermarktungspartner (hier soll es
drei „heiße“ Kandidaten geben) veröffentlichen wird. Selbstverständlich gibt es hier trotz des „approval“ ein kleines
Restrisiko der Ablehnung. Sollte unsere positive Haltung jedoch bestätigt werden, so erscheinen Kurse um die 1,50
CAD mehr als realistisch. Mit dem Management des zweiten Musterdepotwertes, der ARBOmedia AG, treffen wir
uns noch in dieser Woche. Über eventuelle Neuigkeiten werden wir Ihnen dann in der kommenden Ausgabe
berichten. Mit dem heutigen Tage gibt es einen weiteren Wert in unserem Musterdepot – die Aktie der ENRO AG
(siehe Aktie im Blickpunkt). Wir möchten auch an dieser Stelle noch einmal gemäß §34b WPHG darauf hinweisen,
dass Mitarbeiter unserer Redaktion und/ oder mit boersennachrichten.de verbundene beziehungsweise nahe
stehende Gesellschaften Aktien der ENRO AG halten. Allerdings sind wir so von dieser Gesellschaft überzeugt, dass
wir die mögliche Performance weder ihnen noch unserem Musterdepot vorenthalten wollten. Das von uns erwartete
Kursziel für ENRO-Aktien liegt bei 15 Euro. Der Anlagehorizont ist „lang“ und wir gehen davon aus, die Aktien
mindestens bis Sommer dieses Jahres in unserem Musterdepot zu halten.

[Rosenberger]

Antwort auf Beitrag Nr.: 27.029.545 von SharpRatio am 19.01.07 12:18:54

ist schon vergangenheit! ASK seite ist schon höher als die BID seite... mich würde es nicht wundern, wenn heute noch die ersten stopp-losses ausgelöst werden und wir dann wie butter auf das GAP durchmarschieren.

Bid/Ask:
Bid: 0.6
Ask: 0.61

Size
301x327

[Rosenberger]

Antwort auf Beitrag Nr.: 27.032.326 von meislo am 19.01.07 14:46:31

Wir gehen davon aus, dass Nuvo Research die
endgültige Freigabe erhalten wird und diese Ende Februar zusammen mit dem Vermarktungspartner (hier soll es
drei „heiße“ Kandidaten geben) veröffentlichen wird.

das dauert ja dann wohl noch mind. 6 Wochen

[Rosenberger]

wir sind durch die .60!

20:14:41MEZ

Bid: 0.59
Ask: 0.6

Size Bid/Ask:
127x81

[SharpRatio]

Antwort auf Beitrag Nr.: 27.039.246 von Rosenberger am 19.01.07 20:18:51

Es besteht Gefahr dass die 60er Marke fällt. Ich bin erstmal raus. Kann sein, dass sie hält aber aktuell .59 Cent im Geld.

[SharpRatio]

Antwort auf Beitrag Nr.: 27.039.114 von Rosenberger am 19.01.07 20:09:18

Ende Februar also. Interessant. Wo stand dass? (ich bin gerade erst heimgekommen).

[Rosenberger]

Antwort auf Beitrag Nr.: 27.040.263 von SharpRatio am 19.01.07 21:26:36

in einem börsenbrief offenbar...

Bid: 0.58
Ask: 0.59

Size Bid/Ask:
269x200

[Rosenberger]

.56 can dollar

die .49 sehen wir mindestens noch, um das offene GAP zu schliessen.

[Paramedic76]

Hoffentlich, ab Mittwoch bin ich dabei (dann ist das Geld endlich umgeschaufelt), ab dann drücke ich uns die Daumen.

Bis Mittwoch,

[Rosenberger]

Antwort auf Beitrag Nr.: 27.118.737 von Paramedic76 am 22.01.07 20:39:56

das war wohl nichts mit dem offenen GAP. scheinen wohl alle auf news im januar zu spekulieren. wenn da der schuß nun mal nicht nach hinten los geht.

[Stammzelle]

Antwort auf Beitrag Nr.: 27.249.513 von Rosenberger am 28.01.07 14:36:25

Hi Rosenberger,

stimme dir zu, dann wir noch Mal sehr günstig einkaufen können, sofern kommende Woche nichts bahnbrechendes gemeldet wird...

Bin grundsätzlich auch positiv und hoffe sehr, dass es auch kurzfristig klappen wird. Denn och bin ich skeptisch, weil die FDA nun einmal starre Regeln hat. Selbst wenn nichts Besonderes gefordert werden sollte, wird es möglicherweise wieder Monate dauern, bis die Prüfung abgeschlossen sein wird.


Gruß, Stammzelle.

[SharpRatio]

Antwort auf Beitrag Nr.: 27.252.872 von Stammzelle am 28.01.07 16:19:09

Heute präsentiert sich der Titel sehr stark, allerdings ohne News.

[Binsen_t_weisheiten]

Antwort auf Beitrag Nr.: 27.464.813 von SharpRatio am 06.02.07 16:19:48

...na ja, irgendeiner wird wohl in Toronto News haben

mit oder ohne news...mir ist es sehr recht!

[schmacki]

Da tauchen 500000er Bid's gleich reihenweise auf!

[URANI]

Nuvo Research continues Pennsaid discussions with FDA


2007-02-09 07:42 ET - News Release

Mr. Henrich Guntermann reports

NUVO ANNOUNCES UPDATE ON DISCUSSIONS WITH FDA RELATED TO APPROVAL OF PENNSAID

Nuvo Research Inc. is providing an update on discussions with the U.S. Food and Drug Administration regarding the approvable letter issued by the FDA on Dec. 28, 2006, for Pennsaid, a non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis.

In a recent meeting with the FDA, the additional requirements for approval as outlined in the approvable letter were discussed. The matters raised in the approvable letter do not relate to clinical efficacy or clinical safety of Pennsaid as evidenced in Nuvo's phase III trials and the FDA has not requested that Nuvo conduct any additional phase III clinical trials. In order to resolve certain matters raised in the approvable letter, the company may be required to generate additional data before approval.

Nuvo is in continuing communications with the FDA regarding the specifics and timing of the additional information required and the company will provide further updates as the steps toward Pennsaid approval are clarified.

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.547.044 von URANI am 09.02.07 14:30:03

Ein glück das ich nicht mehr investiert bin.

Nuvo announces update on discussions with FDA related to approval of Pennsaid
Friday February 9, 7:00 am ET


- COMPANY ALSO ANNOUNCES RECEIPT OF $7.9 MILLION AS A RESULT OF WARRANT EXERCISE PROGRAM -
MISSISSAUGA, ON, Feb. 9 /CNW/ - Nuvo Research Inc. (TSX: NRI - News) today provided an update on discussions with the U.S. Food and Drug Administration ("FDA") regarding the approvable letter issued by the FDA on December 28, 2006 (the "Approvable Letter") for Pennsaid, a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis.
ADVERTISEMENT


In a recent meeting with the FDA, the additional requirements for approval as outlined in the Approvable Letter were discussed. The matters raised in the Approvable Letter do not relate to clinical efficacy or clinical safety of Pennsaid as evidenced in Nuvo's Phase III trials and the FDA has not requested that Nuvo conduct any additional Phase III clinical trials. In order to resolve certain matters raised in the Approvable Letter, the Company may be required to generate additional data before approval.

Nuvo is in ongoing communications with the FDA regarding the specifics and timing of the additional information required and the Company will provide further updates as the steps toward Pennsaid approval are clarified.

None of the matters outlined in the Approvable Letter were raised by the FDA in its Non-Approvable letter of August 2002 (the "Non-Approvable Letter") to which Nuvo responded when it resubmitted its application for Pennsaid approval in June of 2006.

Nuvo continues to be in discussions with potential partners for the licensing of Pennsaid in the US.

"We are obviously disappointed that approval of Pennsaid may be delayed," said Henrich Guntermann, President and CEO. "We will continue to work with our advisors and the FDA to determine the appropriate path forward to secure the approval of Pennsaid in the U.S."

To meet the FDA's clinical efficacy and clinical safety requirements as outlined in the Non-Approvable Letter, Nuvo conducted study 112, a 12-week Phase III, 5-arm, double-blind trial of 775 patients. This trial enrolled patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. The trial met all of its primary endpoints with respect to pain, physical function and patient overall health assessment. The trial also demonstrated comparable efficacy of Pennsaid to oral diclofenac. To address the long-term safety requirements as outlined in the Non-Approvable Letter letter, Nuvo conducted study 112E, a long-term multi-centre, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis of the knee. In total, 793 patients were treated, including 448 patients for at least six months and 116 patients for at least one year. The key observation was that long-term use did not cause any new, unexpected adverse events.

In total, more than 2,500 patients have been treated with Pennsaid in clinical studies. Pennsaid has been approved in Canada and several European countries and more than 1.5 million prescriptions for Pennsaid have been written to date in those countries.

Early Warrant Incentive Program Update

The Company also announced the results of the warrant incentive program ("incentive program") which was designed to encourage the early exercise of three series of common share purchase warrants by January 31, 2007. In total, 19,548,455 warrants were exercised resulting in gross proceeds of approximately $7.9 million. The proceeds will allow Nuvo to continue executing its current business plan relating to the development and commercialization of Nuvo's pharmaceutical products, primarily its Pennsaid(R) and Pennsaid Plus(R) products.

All remaining warrants will continue to be exercisable for common shares on the same terms that existed prior to the incentive program.

On February 1, 2007, subsequent to the conclusion of the incentive program, the Company had 196.8 million common shares outstanding, 32.6 million warrants outstanding, 16.7 million stock options outstanding and debentures potentially convertible into 14.2 million common shares.

[Paramedic76]

Hmmm,

ich denke das wird dem Kurs vorerst wieder einen Dämpfer verpassen. Bleiben nur noch News einer Kooperation mit einem großen Produzenten.

Positiv finde ich allerdings, daß keine weiteren Klinischen daten gesammelt werden sollen, was man allerdings unter "to generate additional data" zu verstehen hat, erschließt sich mir nicht.

Nun sei es drum, vielleicht kommt ja bis Ende März ein Großer in die Kooperation.

Habe ich es eigentlich richtig verstanden, daß Pennsaid in KAN und EU bereits zugelassen ist? Dann würde eine Kooperation mit John&John ja für den Kurs durchaus eine sofortige Wirkung haben.

Viele Grüße,

[Rosenberger]

@brauche geld... dann solltest du aber die positive meldung nicht in deiner negativen euphorie unterschlagen: denen sind knapp 8 mio euro in die kasse geflossen....

[kurttilly]

Hallo zusammen!

Ich glaube auch, daß das evt. gar keine so schlechte Meldung war!

Vielleicht wird noch Positives daraus!

mfg kurttilly

[schmacki]

Wie heisst es so schön:Fast jedes Gap wird geschlossen.

[kurttilly]

geht´s schon wieder nach oben ????


Realtime-Kurs09.02.07 Kurs € Zeit Volumen
Geld 0,40 15:31:07 74.500 Stk.
Brief 0,42 15:31:07 50.000 Stk


kurttilly

[URANI]

[Rosenberger]

Antwort auf Beitrag Nr.: 27.547.949 von schmacki am 09.02.07 15:10:00

da ist was dran

[Rosenberger]

0,25 Can dollar

Nuvo announces first quarter 2007 financial results
MISSISSAUGA, ON, May 1 /CNW/ - Nuvo Research Inc. (TSX: NRI) today
announced its fiscal and operational results for the first quarter ended March
31, 2007.

<<
First Quarter Highlights

During the first quarter the Company:

- Raised an additional $5.2 million from its earlier announced early
warrant incentive program;

- Continued discussions with the FDA regarding the Approvable Letter
that confirmed Pennsaid could be approved for sale in the U.S. once
certain conditions were satisfied. None of the conditions relate to
the clinical efficacy or clinical safety of Pennsaid, which were
evidenced in Nuvo's Phase III trials. Based on these discussions, the
Company commenced studies that it expects to conclude in time to file
a response to the FDA in the fourth quarter of 2007. The Company
continues to correspond with the FDA to resolve other matters raised
in the Approvable Letter including whether Nuvo should have to
evidence the dermal safety of Pennsaid and its constituent components
through longer term dermal animal safety studies. The Company remains
hopeful that, based on the abundance of dermal safety data that it has
submitted to the FDA, these studies will not be required or, if
required, may be submitted post approval. Should the FDA require the
Company to conduct these studies pre-approval, final U.S. approval for
Pennsaid would be delayed to 2010/2011;

- Continued to validate, broaden and extend its proprietary formulations
platform technology, multiplexed molecular penetration enhancer
(MMPE(TM)) technology. This process has yielded several attractive
transdermal product possibilities. Patent protection for several
MMPE(TM) systems have been applied for.
>>

"Our top priority remains final approval of Pennsaid in the U.S. As such,
we will continue our discussions with the FDA to resolve matters raised in the
approvable letter as rapidly as possible," said Henrich Guntermann, President
and CEO. "At the same time, we progress closer to our vision of becoming a
leading transdermal delivery company. Our San Diego based Research and
Development facility, fqubed Inc., has discovered several attractive
transdermal product possibilities in our core area of focus, pain, and in
other areas, using our proprietary MMPE(TM) technology. We are continuing to
pursue these potential new products and to broaden our transdermal product
pipeline with further development of new product formulations."
Nuvo continues to be in discussions with potential partners for the
licensing of Pennsaid in the U.S. Prospective licensees are proceeding
cautiously until the timing of the approval of Pennsaid by the FDA is
clarified.

<<
Financial Results:

Three months Three months
ended ended
March 31, 2007 March 31, 2006
-------------------------------------------------------------------------
Revenue $ 978 $ 633
Loss from operations (3,487) (3,718)
Net loss $ (3,487) $ (2,771)
-------------------------------------------------------------------------
>>

Product and research contract revenue for the three-months ended
March 31, 2007 increased 49% to $728,000 compared with $489,000 for the
three-months ended March 31, 2006. This increase was primarily a result of the
137% increase in Pennsaid revenue which reflects initial orders related to the
launch of Pennsaid in Greece by our distributor Vianex S.A. as well as an
increase in orders from our Italian distributor. In Canada, shipments of
Pennsaid to Canadian wholesalers in the first quarter increased by 6% over the
comparable quarter last year but our reported Canadian sales were down 8% as
Squire, our Canadian marketing partner, continued to adjust their inventory
levels.
During the quarter ended March 31, 2007, Nuvo recorded $250,000 in
license fee revenue that was previously deferred, compared with $144,000 for
the comparable quarter ended March 31, 2006. This represents the systematic
recognition of a portion of the up-front fees received from Squire in 2005 and
2006 for the Canadian marketing rights for Pennsaid.
Total operating expenses of $4.1 million for the three-month period ended
March 31, 2007 were unchanged from a year ago. However, the mix of costs did
change as increases in research and development and selling, general and
administrative expenses were offset by increased margin on higher revenue,
lower levels of stock-based compensation expense and a decline in interest
expense due to higher cash balances and lower debt levels.
Included in operating expenses are research and development (R&D) costs
which were $1.7 million for the three-month period ended March 31, 2007
compared with $1.5 million for the three-months ended March 31, 2006. The
increase is attributable to activities surrounding the Pennsaid approvable
letter and the expansion of formulation and enhancer development activities at
fqubed, our US based research facility. During the current quarter the Company
established a Pennsaid project team to begin preparing the "roadmap" to
address each of the FDA's issues as outlined in the December 2006 Approvable
letter. As part of this process, the team has used several outside consultants
to assist in determining appropriate responses to each issue and design any
required study protocols. During the quarter the Company began the first of
these studies and was preparing others to begin during the second quarter.
In the comparable period ending March 31, 2006 the Company completed the
analysis of the Pennsaid Phase III efficacy and safety trial (designated
'Study 112') and the Pennsaid Phase III long-term open-label safety trial
(designated 'Study 112E') which were a key part the Company's submission in
June 2006 leading to the FDA approvable letter for Pennsaid received in
December 2006. Research and development costs are expected to increase versus
2006 over the remainder of 2007 as the Company conducts the studies necessary
to address the issues raised in the Approvable Letter and engages in a higher
level of activity at fqubed.
The loss from operations for the three-months ended March 31, 2007 was
$3.5 million versus $3.7 million in the three-months ended March 31, 2006. In
January 2006 the Company sold its former head office in Markham, Ontario for
$2.7 million, net of commissions and closing costs resulting in a gain of
$0.9 million. As a result, the net loss for the three-months ended March 31,
2007 was $3.5 million compared with $2.8 million for the three-month period
ended March 31, 2006. The net loss per common share was $0.02 in both periods.
Cash and cash equivalents increased to $13.2 million at March 31, 2007,
compared to $11.2 million at December 31, 2006 as cash provided by financing
activites of $5.0 million was only partially offset by cash used by operating
activities of $3.0 million.
During the first quarter of 2007, the Company generated $5.0 million in
net cash from financing activities that included $5.3 million from the
exercise of warrants offset by $328,000 in long-term debt and capital lease
repayments. In the comparable period, the Company generated $3.6 million from
financing activities the most significant of which were the transactions
whereby the Company sold additional Pennsaid licensing rights in Canada to
Squire Pharmaceuticals Inc. for proceeds of $3.75 million, including a
$3.25 million upfront payment.
Detailed financial statements and the MD&A are available at
www.nuvoresearch.com or www.sedar.com.

Corporate Development:

Subsequent to quarter end, a settlement agreement was reached between
Nuvo Research Inc. (formerly Dimethaid Research Inc.) and the Ontario
Securities Commission (the "Commission"). The settlement provided that an
independent expert would review Nuvo's disclosure practices and policies and
that Nuvo would contribute $15,000 towards the cost of the investigation. No
fine or other penalty was assessed. The matter relates to the failure to
disclose a non-approvable letter for Pennsaid received from the US FDA in
August of 2002. After the new board of directors and management team took
control of the Company on September 21 2004, they discovered the existence of
the non-approvable letter, and disclosed it in a press release dated
October 6, 2004.

Notice of Annual Special Meeting

Nuvo will be holding its Annual Meeting of Shareholders on Tuesday,
May 1, 2007 at 9:00 a.m. (EST) at the Gallery of the Toronto Stock Exchange
(TSX) Broadcast & Conference Centre, The Exchange Tower, 130 King Street West,
Toronto, Ontario, Canada.
Nuvo Research Inc.'s Annual and Special Meeting will be webcast in real
time. The webcast can be viewed online starting at 9:00am at
www.nuvoresearch.com, and will be archived for 12 months.

About Pennsaid

Pennsaid(R) is a topical non-steroidal anti-inflammatory drug (NSAID)
used for the treatment of osteoarthritis and is currently approved for sale in
Canada and several European countries. Pennsaid(R) allows the diclofenac
solution to be delivered to a specific site via the surface of the skin and
thus limits complications associated with systemic delivery. According to
published clinical trials, Pennsaid(R) is as effective as the maximum daily
dose of comparable oral medication at relieving pain and stiffness associated
with osteoarthritis of the knee, as well as improving overall well-being.
There is currently no topical NSAID product approved in the approximately
$4 billion U.S. osteoarthritis pain relief market. In December 2006, the U.S.
Food and Drug Administration issued an approvable letter that indicated
Pennsaid(R) is approvable subject to Nuvo satisfying certain conditions.

About Nuvo Research Inc.

Nuvo is focused on developing innovative site-specific therapeutics that
are delivered topically using the Company's skin-penetrating technologies.
Nuvo's lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory
drug (NSAID) used for the treatment of osteoarthritis. Nuvo intends to
leverage its skin-penetrating technologies to create a portfolio of
transdermal products targeting a variety of indications. Nuvo Research Inc. is
a publicly traded, Canadian pharmaceutical company headquartered in
Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and
Wanzleben, Germany and a research and development facility in San Diego,
California. For more information, please visit www.nuvoresearch.com.

This release may contain forward-looking statements, subject to risks and
uncertainties beyond management's control. Actual results could differ
materially from those expressed here. Risk factors are discussed in the
Company's annual information form filed with the securities commissions in
each of the provinces of Canada. The Company undertakes no obligation to
revise forward-looking statements in light of future events.

<<
Summary financial statements attached:

[Stammzelle]

Hi,

kann man als Fazit ziehen, dass Pennsaid wohl erst 2010/ 2011 zugelassen wird...


Gruss, Stammzelle

[Binsen_t_weisheiten]

Antwort auf Beitrag Nr.: 29.196.580 von Stammzelle am 07.05.07 21:22:22

das sind ja irre news ...