Biomira Long-Term Sentiment +++StrongBuy+++ - 500 Beiträge pro Seite

[[KERN]Codex]

http://www.wallstreet-online.de/ws/community/board/threadpag…


Thread: Biomira zweiter Anlauf mit den biotherapeutischer Impfstoff BLP25

http://www.biomira.com/home/main/

[verdi2003]

Hallo [KERN]Codex!

Bei Biomira muss man einfach abwarten bis
die Zulassung in fünf Monaten erteilt wird.

Vielleicht kommt sie schon pünktlich zum Weihnachten.
Das wäre dann ein großes Geschenk



Gruß
verdi

[Frank...Drebin]

@ verdi


Ich glaube es wird nichtb zu einer Zulassung kommen die sammeln jetzt schon wieder Geld für ihre Kriegskasse obwohl Sie mit Merk einen Finanzstarken Partner haben.

[[KERN]Codex]

Aber die neuen Aktien sind weggegangen wie warme Semmeln

[[KERN]Codex]

Klar kommt es zur Zulassung.. les doch mal im Thread von Donnerpower..

-----------------------------------------------------------
Price vs. Vol distribution last 9 days
by: imx_pgy2 12/16/04 09:28 am
Msg: 171406 of 171409

This is the price vs. vol distribution of all shares traded over the last 9 days. The distribution is bi-modal with the greatest majority of trades roughly at 3.5 and then 2.65.

Price Vol (in thousands)
2.4 764
2.5 10749
2.6 17471
2.7 16116
2.8 14100
2.9 8318
3.0 6906
3.1 9372
3.2 13500
3.3 9655
3.4 18951
3.5 21676
3.6 16700
3.7 9656
3.8 4174
3.9 9492
4.0 6876
-----------------------------------------------------------

[freetibet]

@frank...

Wenn eine Zulassung nicht im Bereich des Möglichen wäre,
dann wäre Merck schon ausgestiegen (siehe Theratope).
Die haben schon genug investiert.

Was meinst Du denn mit Kriegskasse?

[[KERN]Codex]

Microsoft hat ne Kriegskasse, aber BIOM doch nicht

Taxe in Berlin:

Geld 1,95
Brief 2,01
Zeit 16.12.04 15:45:18

[Frank...Drebin]

nun solche auswüchse im Kurs waren nun als zu oft bei BIOM.
ich bin da sehr vorsichtig mit den zulassungen.


nun Kriegskasse da ist das Geld zum überleben drin


Microsoft hat seine Kriegskasse gelehrt

[Frank...Drebin]

@ codex

hier in Deutschland kenn doch kaum einer BIOM.

[BIOMIRA]

biom ist ein MILLIARDEN MARKT, den IHNEN dann keiner streitig machen kann
da hat es so manche biofirma schwerer


die zulassung wird kommen
gruß
biom

[[KERN]Codex]

#8


Stimmt kennen noch ziemlich wenig Leute diese geile Aktie und es ist auch noch genug Zeit sich zu positionieren (zumindest Heute) - Ich denke die FDA wird das Ding zulassen, das Medikament hat sogar den FastTrack Status, d.h. es geht noch schneller..

[Frank...Drebin]

Hi Biomira

reicht es nicht erst mal milonen Markt?

[Frank...Drebin]

codex frag mal bei WO nach ob einer BIOM kennt


da kommt bestimmt die frage haben Frick und Förtsch die in der Hotline besprochen

[[KERN]Codex]

ne MILLIONEN bekommen ja schon LottoGewinner..


Milliarden !

[Frank...Drebin]

Ich tipp mal Schlußkurs Heute abend 2,80 $ aber nicht verhauen

[eis123]

Wir geben uns nicht mit Millionen ab, die meisten Deutschen sind ja schon Millionäre, braucht euch nur umzu schauen, bzw. selbst anschauen. Alle haben eine Eigentumswohnung, eine vermietet Immobilie, einen BMW, Porsche Audi oder Mercedes oder mehrere Häuser.

Also -> Milliarden!!!

[[KERN]Codex]

-----------------------------------------------------------
so much enthusiasm worldwide i hear
by: kidzdoc97
Long-Term Sentiment: Strong Buy 12/16/04 10:04 am
Msg: 171419 of 171419

the fda will keep to their <=6months from the final submission.

we will be on the market by summer 2005!!!!!!

wait and see. just chuckle at the bashers who come on record (with no vested interest) and no knowledge other than to see their plans dampened by so much enthusiasm.

k
-----------------------------------------------------------

[BIOMIRA]

also selbst @DONNERPOWER mit seinen sehr TIEFSTAPELNDEN WORTEN redet vom MILLIARDEN MARKT

[BIOMIRA]

KUAFT in GERMANY

MÜNCHEN SEHR FAIRE PREISSTELLUNG !!
Frankfurt ist aber auch o.k.

der € wird eine automatische steigerung herbeiführen !



doppeltop bei 1,344

ziel 1,2

die % könnt ihr auch noch mitnehmen

[Frank...Drebin]

wird auch Zeit mit dem Euro

[eis123]

Wir rutschen also auch heute wieder ins minus, schade. Am Anfang gehts gut los, das Ende ist dann ein Trauerspiel. Umgekehrt wäre es mir lieber.

[[KERN]Codex]

#19

Gutes Posting..

[[KERN]Codex]

Sehr gesund, 2,5$ scheint ein guter Boden zu sein! (1,89€)
Mein Euro-Ek liegt bei 2,11€, aber die sind bald doppelt wieder raus..

Der Bauplan für die Untertasse schockt :P

mfg

[[KERN]Codex]

Achtet mal drauf, keine großartigen Verkaufssignale beim MACD, 2,5$ (1,89€) scheint ein guter Boden zu sein!

[[KERN]Codex]

hihi

[[KERN]Codex]

Die Indikatoren stehen heute auf Kauf, da es bad news für einen Konkurrenten gab!

Im Hoch heute plus 10,8% (2,77$)



gruß codex

p.s. news im thread von donnerpower

[[KERN]Codex]

Kleiner Rückblick:


Pull from 12.31.2003 40f filing

- Collaborations

"In May, 1997 the Company entered into a collaboration agreement with Chiron Corporation (“Chiron”) of Emeryville, California pursuant to which agreement the Company and Chiron agreed to co-develop Biomira’s Theratope vaccine. On June 29, 2000, Biomira announced that it had exercised its option to reacquire all rights held by Chiron under the collaboration agreement. As a result, Biomira is required to make a payment to Chiron in the amount of U.S. $3.25 million upon regulatory approval and commercialization of Theratope vaccine in the United States.

On May 3, 2001, Merck KGaA of Darmstadt, Germany and Biomira announced that they had entered into a global product development, licensing and co-promotion collaboration for Biomira’s two most advanced therapies –Theratope vaccine and BLP25 liposomal vaccine (discussed below). The collaboration covers the entire field of oncology for these two products. Under the terms of the collaboration, Merck KGaA and Biomira will co-promote the products (when approved) in the U.S. The co-promotion activities of Merck KGaA in the U.S. are planned to be conducted through its U.S. affiliate, EMD Pharmaceuticals, Inc. Biomira will retain marketing rights in Canada. Merck KGaA will have sole development and marketing rights in relation to the products in the rest of the world with the exception of Israel and the Palestinian Autonomy Area for which agreements were already in place. Biomira received an up-front cash payment and equity investment. Biomira will also receive significant cash and equity investments for Biologics License Application (BLA) submissions for first and second cancer indications, on regulatory approvals for first and second cancer indications, and for sales milestones. The total potential value of the collaboration to Biomira is more than U.S. $150 million in license fees, milestone payments and equity investments. The parties will share equally development and specified marketing costs in the U.S. and Canada, and Merck KGaA will be responsible for clinical studies, regulatory compliance and marketing outside of the U.S. and Canada. The two companies will share evenly the external costs associated with continued clinical development of the products, retroactive to January 1, 2001. Biomira will manufacture the vaccines for worldwide use. With respect to product sales in the U.S. and Canada, the parties will be entitled to an equal share of such revenues, and Biomira will be entitled to receive royalties on product sales for all other territories."

[[KERN]Codex]

Rückblick aller "Collabos":


Collaborations
Biomira has benefited from an ongoing relationship with the University of Alberta and continues to benefit from collaborative relationships with individual researchers and consultants at leading scientific and clinical institutions. Such relationships provide ongoing assistance with the assessment of Biomira`s scientific and clinical work as well as with development of its products.

University of Alberta

Pursuant to an agreement dated February 25, 1986, between Biomira, the Governors of the University of Alberta, Almiria Capital Corp and Bioalta Inc., the University granted all its present and future rights to certain technology to Biomira. "Technology" means all technical information, discoveries and inventions, including all patents, trade marks, know-how and other intellectual property rights relating to monoclonal antibodies, synthetic antigens and other matters.

AltaRex

In connection with the sale of certain tangible assets to AltaRex Corp in November 1995, Biomira entered into a license agreement with AltaRex wherein Biomira granted an anti-idiotype induction therapy field of use license for its antibody MAb B43.13. Biomira received a one time up front payment from AltaRex and will receive royalties from AltaRex based on sales of products (such as OVAREX™) using the MAb B43.13 antibody for anti-idiotype induction therapy applications.
In September, 1999, the license agreement was amended and restated to clarify and modify certain terms of the license agreement that had given rise to issues raised by each of the parties.

University of Minnesota

Biomira USA (OncoTherapeutics, Inc.) acquired an exclusive worldwide license from the University of Minnesota on June 6, 1991 in relation to the University of Minnesota`s technology for culturing lymphocytes, methods of treatment using such lymphocytes and liposome immunoadjuvants containing IL-2.

United States Public Health Service

In February 1994, a permit for joint research between the United States National Cancer Institute and Biomira USA was approved. In September, 1997 Biomira USA executed an exclusive patent license agreement with the United States Public Health Service relating to technology and certain patent rights held by the PHS.

Hoffmann - La Roche

In September 1994, Hoffmann-La Roche granted to Biomira USA certain rights, in exchange for certain reciprocal rights from Biomira USA, regarding Interleukin-2 in combination with liposomes. The agreement extends through the issuance of patents for so long as such patents remain in effect or for twenty years following a product launch, whichever is later. The agreement contains provisions regarding royalties, confidentiality and indemnification.

Chiron Corporation

In May, 1997 the Company entered into a collaboration agreement with Chiron Corporation pursuant to which agreement Biomira and Chiron agreed to co-develop Biomira’s Theratope vaccine. On June 29, 2000, Biomira announced that it had exercised its option to reacquire all rights held by Chiron under the collaboration agreement.
As a result, Biomira is required to make a payment to Chiron in the amount of U.S. $3.25 million upon regulatory approval and commercialization of Theratope vaccine in the United States.

Merck KGaA

On May 3, 2001, Merck KGaA of Darmstadt, Germany and Biomira announced that they had entered into a global product development, licensing and co-promotion collaboration for Biomira’s two most advanced therapies –Theratope vaccine and BLP25 liposomal vaccine (discussed in Activity).
The collaboration covers the entire field of oncology for these two products. Under the terms of the collaboration, Merck KGaA and Biomira will co-promote the products (when approved) in the U.S.
The co-promotion activities of Merck KGaA in the U.S. are planned to be conducted through its U.S. affiliate, EMD Pharmaceuticals, Inc.
Biomira will retain marketing rights in Canada. Merck KGaA will have sole development and marketing rights in relation to the products in the rest of the world with the exception of Israel and the Palestinian Autonomy Area for which agreements were already in place.
Biomira received an up-front cash payment and equity investment. Biomira will also receive significant ca!sh and equity investments for Biologics License Application (BLA) submissions for first and second cancer indications, on regulatory approvals for first and second cancer indications, and for sales milestones.
The total potential value of the collaboration to Biomira is more than U.S. $150 million in license fees, milestone payments and equity investments.
The parties will share equally development and specified marketing costs in the U.S. and Canada, and Merck KGaA will be responsible for clinical studies, regulatory compliance and marketing outside of the U.S. and Canada.
The two companies will share evenly the external costs associated with continued clinical development of the products, retroactive to January 1, 2001. Biomira will manufacture the vaccines for worldwide use. With respect to product sales in the U.S. and Canada, the parties will be entitled to an equal share of such revenues, and Biomira will be entitled to receive royalties on product sales for all other territories.

CancerVac Pty Ltd

On March 10, 2004, Biomira announced the entering into with Prima BioMed Ltd and CancerVac Pty Ltd (a subsidiary of Prima) of a license and development agreement for the development and commercialization of CancerVac`s most advanced cancer vaccine product candidate, a Mannan-MUC1 fusion protein therapeutic vaccine.
Under the terms of the agreement, Biomira will provide CancerVac with access to its licensed rights related to MUC1 for purposes of the development of this product candidate.
In partial consideration for the licensed rights provided by Biomira to CancerVac, Biomira acquired a 10% equity stake in CancerVac and a seat on the board of directors of CancerVac. The agreement also provides Biomira with the sole option of licensing the exclusive worldwide or North American rights to CancerVac`s Mannan-MUC1 fusion protein therapeutic vaccine (with commensurate up-front, milestone and royalty payments) following the conclusion of the Phase IIa trial of the vaccine in patients with ovarian cancer.
CancerVac plans to initiate patient recruitment into the Phase IIa trial in the second quarter of 2004. In the event Biomira does not exercise its licensing option, then the agreement enables CancerVac to develop and commercialize its product candidate with equivalent up-front, milestone and royalty payments to Biomira.

Other

From time to time, Biomira enters into other research and technology agreements with third parties under which research is conducted and monies expended. These agreements outline the responsibilities of each participant and the appropriate arrangements in the event the research produces a commercialized product.

Biomira also has licensing agreements to use proprietary technology of third parties in Biomira`s research and development. If this research ultimately results in a commercialized product, Biomira has agreed to pay certain royalties and licensing fees.

[[KERN]Codex]

[[KERN]Codex]

BUY ORDERS
100 2.4900
28,100 2.4800
1,500 2.4700
1,400 2.4600
2,900 2.4500
400 2.4400
400 2.4300
400 2.4200
1,850 2.4000
2,000 2.3800
62 Buy Orders

SELL ORDERS
3,300 2.5000
1,500 2.5100
1,900 2.5200
2,100 2.5300
3,600 2.5400
400 2.5500
400 2.5600
2,400 2.5700
1,400 2.6100
11,000 2.6400

Konsolidierung geht weiter, mit neuen Engagements kann man noch n bissel warten Falls die 2,49/2,50 hält sollte man sich schleunigst positionieren

[[KERN]Codex]

BUY ORDERS
5,500 2.4700
37,100 2.4600
4,900 2.4500
400 2.4400
400 2.4300
400 2.4200
921 2.4100
3,050 2.4000
2,000 2.3800
1,700 2.3700

SELL ORDERS
200 2.4900
2,800 2.5000
2,000 2.5100
400 2.5200
500 2.5300
400 2.5400
400 2.5500
400 2.5600
2,000 2.5700
6,000 2.6000

So nun sind wir doch unter 2,49$ gerutscht

[[KERN]Codex]

Ich wünsche allen ein Frohes Neues erfolgreiches Jahr 2005

[BIOMIRA]

THX

ich bin auf den ersten handelstag gespannt
denke da wollen ein paar tax seller rein

biom

[[KERN]Codex]

Meeting: 2004 ASCO Annual Meeting
Category: Health Services Research

Report card for accelerated FDA approval oncology drugs (1995- 2003): Is it time for a make-up test?

Abstract No: 6002

Citation: Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 6002

Author(s): S. M. Belknap, E. A. Lyons, J. M. McKoy, C. L. Bennett; Northwestern University, Chicago, IL

Abstract: Background: The FDA adopted accelerated approval in 1992 in order to improve access to new drugs based on studies that evaluated markers likely to predict clinical benefit. Methods: The performance of this program was assessed by reviewing new oncology licensing applications and supplements for new uses approved by the FDA from 1995 to September 2003. Data included: the application filing date for each agent, the date of approval, the types of studies that were assessed during FDA review, and the endpoints used in these studies. Results: Of the 21 oncologic indications which received accelerated FDA approval, subsequent studies that were required for conversion to regular approval were submitted and accepted (n=5) [capecitabine, dexrazoxane, docetaxiel, imitinab mesylate, irinotecan], submitted for regular approval but rejected by the FDA (n=3), or have not been submitted (n=14). Surrogate outcomes included response rate (n=16), symptom improvement (n=1) and reduced time to recurrence (n=1). Fourteen approvals were based on results of phase II clinical trials, while only 5 were based on phase III studies. Fewer than 200 patients were evaluated for efficacy for about 2/3 of the indications. Post-marketing studies identified potentially fatal adverse drug reactions for four of the drugs, three of which were identified within 7 months of initial FDA approval (capecitabine-associated interaction with warfarin, imatinib-associated hemorrhage in GIST, and gemtuzumab-associated VOD). Conclusions: To date, drugs which have received accelerated FDA approval have been frequently evaluated in small, short-term phase II clinical trials, have rarely been converted to regular FDA approval, and can have potentially fatal adverse drug reactions identified in the first year of marketing.

gruß codex

[manyman]

Unbedingt Vartis anschauen!!!
WPKN 691190!!!
Orderbuch zwischen 9,30 und 10,80 leer!!

250 8,45
200 8,55
200 8,60
400 8,61
1 850 8,80
1 230 8,88
2 100 8,90
1 200 9,00
1 000 9,01
300 9,02
9,18 100
9,19 1 500
9,20 3 400
9,25 1 000
9,26 700
9,30 1 000
10,80 800
10,90 48
11,88 820
12,18 700

8 730 Ratio: 0,867 10 068

[[KERN]Codex]

hey manyman du nubi
Kannst nicht lesen?

[[KERN]Codex]

[BIOMIRA]

puhhhhhhhhhhhhhh bin etwas enttäuscht
hatte gedacht die amis legen heute ne BIOM party hin


--------------------- müssen wir leider auf die news warten-----

schade
biom

[[KERN]Codex]

Abwarten!

[[KERN]Codex]

UP

[[KERN]Codex]

BLP25 accelerated coditional approval
by: tloutrec (60/M/Spartanburg)
Long-Term Sentiment: Strong Buy 01/03/05 05:28 pm
Msg: 175670 of 175674

Two requirements for FDA accelerated conditional approval.

1) Drug must show some evidence of benefit. Surrogates such as tumor shrinkage can be used, but the "Gold Standard" (FDA`s words, not mine) is increased survival. BLP25 showed a 4.4 month increase in survival for the entire IIb trial and a 10+ month advantage for the stage III suggroup.

2) Drug must be "reasonably likely" (the FDA`s words) to provide benefit. BLP25 demonstrated a p=0.11 in the total patient population IIb trial, which simply means that there is an 89% likelihood that the survival advantage is real. The stage III patients on BLP25 have not yet reached MST, so p value cannot yet be calculated, but it will certainly be <.05, meaning that there is a 95%+ chance that the survival advantage is real.

Both requirements have been met. BLP25 will receive accelerated conditional approval. No doubt about it.

On the day that conditional approval is announced, the stock price will skyrocket to...$15?...$20?...$30?...higher? Do you want to still be waiting to decide if you want in when that happens? The window of opportunity is now. [/i}

[Frank...Drebin]

# 41

15 bis 30 $

[BULLE2004]

Ist das heute nicht eine gute Nachkaufgelegenheit.

[Frank...Drebin]

ja aber geh nicht von einen Kursziel von 15 und mehr $ aus

[versager69]

warum sollte das kursziel(bei zulassung) nicht realitisch sein??

[[KERN]Codex]

Frank gibt sich mit 30$ noch nicht zufrieden
Naja wir werden sehen, spätestens in einem halben Jahr denke ich

#43
Ja super Gelegenheit, seh ich auch so

gruß codex

p.s.

Für ein Jahr Lebensverlängerung zahle ich auch 50$

[Frank...Drebin]

ja Kern in 15 jahren wenn alles klappt

[[KERN]Codex]

Buy
Keep Cool

[[KERN]Codex]

#40

Bei den "Monsterumsätzen" dürfte es heute noch ein Stück weiter gehen

[DausendUndMehr]

#50 Helau!

hoffen wir es!

[[KERN]Codex]

hm das kleine stückchen zu beginn, das wars dann leider

[Andreolly]

Aggregated BookViewer for BIOM
Name
Biomira Inc

Last Price
2.4900

Net Change
+0.1400

Shares Matched
85,600

Orders Entered
877

Last Match Time
10:06:26.194
Market
NM

Previous Close
2.3500

Percent Change
+5.96%

Shares Entered
873,531

Open Orders
135

Last Order Time
10:06:31.661
BUY ORDERS
SHARES PRICE
200 2.4900
2,100 2.4800
1,900 2.4700
1,000 2.4600
3,600 2.4500
200 2.4400
200 2.4300
200 2.4200
200 2.4100
900 2.4000
57 Buy Orders
SELL ORDERS
SHARES PRICE
2,200 2.5000
6,650 2.5100
2,200 2.5200
200 2.5300
7,600 2.5400
1,200 2.5500
200 2.5600
1,200 2.5700
4,652 2.6000
3,000 2.6300
78 Sell Orders