Zulassungs-Phantasie -- Nur noch 6 Tage - 500 Beiträge pro Seite

[BrauchGeld]

Kann man bei dieser Aktie eigentlich noch was falsch machen ?
Allein Cip-Fenofibrate(Cholesterin-Senker 1,1 mrd$ markt)ist mehr wert wie das ganze Unternehmen ,und falls die FDA mitspielt und Cip-Isotretinoin in den kommenden tagen zulässt dann wird es mit sicherheit zu einem gewaltigen kurssprung kommen .
Was mir noch gefällt ist das der Ceo nach wie vor etwa 9,5 mio aktien hält und das der zweitgrösste investor Corriente Master Fund
seinen bestand um weitere 364.800 aktien für ~3,55 C$ erhöht hat.
Ich hab in den letzten zwei wochen wieder ein paar eingesammelt (4000st 1,70) ich denke das abwärtsrisiko ist minimal aber dafür gewaltiges aufwärtspotential vorhanden.

toi toi toi

Cipher Pharma (DND.TO)

Marktkap: 48 mio C$ ( 33 mio€ )<<< viel zu niedrig bewertet
Cash: 12,1 mio C$ ( 8,3 mio€ )
Shares Out: 24 mio
Kurs: 2 C$ (1,37 €)

Cip-Fenofibrate (Hyperlipidemia ) ist bereits in USA (verkaufsstart anfang 4Q 2007) und Kanada (seit 2Q 2007 am markt erhältlich) zugelassen .

Cip-Isotretinoin (Severe acne) hat zum zweiten mal einen approvable letter von der FDA erhalten ,inzwischen wurde alles eingereicht und eine antwort von der FDA ist innerhalb der nächsten 6 tage zu erwarten .

Cip-Tramadol (Moderate to severe pain) hat auch anfang Mai einen approvable letter erhalten .

http://canadianinsider.ca/coReport/allTransactions.php?ticke…

[BrauchGeld]

Cipher reports second quarter fiscal 2007 results
Tuesday July 24, 7:00 am ET


Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, July 24 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced its financial and operational results for the three and six months ended June 30, 2007.

Q2 2007 Summary
---------------
- CIP-FENOFIBRATE introduced in select Canadian markets, resulting in
the Company's first product revenues
- Received second approvable letter from the U.S. Food and Drug
Administration (FDA) pertaining to New Drug Application (NDA) for
CIP-ISOTRETINOIN
- Received approvable letter from the FDA pertaining to NDA for once-
daily tramadol
- Continued progress preparing for commercialization of CIP-FENOFIBRATE
in the U.S., including commercial scale-up and manufacturing of
validation batches
- Subsequent to quarter end, entered into a licensing and distribution
agreement with ProEthic Pharmaceuticals under which ProEthic was
granted the exclusive right to market, sell and distribute
Lipofen(TM) in the United States

"The second quarter was highlighted by important commercialization milestones for our lead compound, CIP-FENOFIBRATE, as we recorded our first product revenues and, subsequent to quarter end, completed a distribution agreement targeting the $1.1 billion dollar United States fenofibrate market," said Larry Andrews, President and CEO of Cipher. "In addition, we received approvable letters from the FDA for our once-daily tramadol and novel isotretinoin formulations. Our team is working diligently to achieve the remaining milestones as we pursue final approval for these two products in the U.S. market."
Financial Review

----------------

Revenue from product sales was recorded for the first time in the second quarter of 2007 as a result of shipping CIP-FENOFIBRATE to Oryx Pharmaceuticals Inc., Cipher's marketing partner for this product in Canada. Product revenue in the second quarter was $227,000.

Research and development (R&D) expenses for the second quarter of 2007 were $0.6 million, compared with $4.3 million in the second quarter of 2006. The decrease in R&D spending reflects the advanced stage of development of the Company's current products. Operating, general and administrative (OG&A) expenses for the second quarter of 2007 were $1.5 million, compared with $0.8 million in the same period last year. The increase in OG&A is due to higher compensation expense resulting from an increase in personnel to support current growth plans as well as stock options expense. Net loss for the three months ended June 30, 2007 was $2.1 million ($0.09 per basic and diluted share), compared with a net loss of $4.9 million ($0.21 per basic and diluted share) in the same period last year.

As at June 30, 2007, Cipher had cash and cash equivalents of $12.1 million, compared with $15.1 million as at December 31, 2006.


Product Update
--------------


During the second quarter of 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol. In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution of certain issues, including a request for an additional adequate clinical trial to provide further efficacy data. In subsequent discussions with the FDA, Cipher has obtained clarification on the question of efficacy. The FDA has indicated that the statistical methods used to analyze data from Cipher's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials. Cipher believes its submission includes sufficient efficacy data to support regulatory approval. The Company is currently finalizing next steps regarding the best path forward toward regulatory approval.
During the second quarter of 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls (CMC), which the Company has responded to, the FDA has requested that Cipher provide additional clinical safety data. Cipher believes that the clinical question raised has been adequately addressed in the NDA submission. The Company appealed the position taken by the FDA in its approvable letter using the Formal Dispute Resolution process. Cipher submitted its appeal and met with the FDA on July 11, 2007. A response from the FDA is expected within 30 days of this meeting.

In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen in the United States, its territories and possessions. Under the terms of the agreement, Cipher will receive an up-front licensing fee of US$2 million. Cipher could receive additional milestone payments of up to US$20 million based on the achievement of certain net sales targets. Cipher will also receive a royalty on a percentage of net sales, which escalates from the mid-teens to mid-twenties based on annual sales targets and the level of promotional effort by ProEthic. After any direct product-related expenses are deducted, approximately 50 per cent of all milestone and royalty payments will go to the Company's technology partner, Galephar Pharmaceutical Research, with Cipher retaining 75 per cent of Galephar's share of these payments until its US$2.0 million investment in Galephar preferred shares is recovered. The agreement with ProEthic is for a period of ten years and they have the right to extend the term for additional two-year periods. ProEthic expects to launch the product in the early part of the fourth quarter of 2007.

During the second quarter of 2007, Oryx Pharmaceuticals introduced CIP-FENOFIBRATE in select Canadian markets. The response to these early sales and marketing efforts will determine longer-term plans for the Canadian market.

[superzausel]

laßt uns alle investieren & auf VIELE VIELE .....

LANGE GRÜNE TAGE HOFFEN....


Gruß SuZau

[BrauchGeld]

Vielleicht erwartet uns wieder so ein rasanter anstieg wie Januar 2006 als Cip-Fenofibrate zugelassen worden ist damals hatte ich vorbörslich noch zusätzlich ein paar tausend stücke ergattert und so richtig geld verdient mit Cipher .

Hier der alte Cipher thread
Thread: Aktie mit hardcore Potential


http://www.cipherpharma.com/downloads/DND_Presentation_Jan20…

[BrauchGeld]

Vielleicht erwartet uns wieder so ein rasanter anstieg wie Januar 2006 als Cip-Fenofibrate zugelassen worden ist damals hatte ich vorbörslich noch zusätzlich ein paar tausend stücke ergattert und so richtig geld verdient mit Cipher .

Hier der alte Cipher thread
Thread: Aktie mit hardcore Potential


http://www.cipherpharma.com/downloads/DND_Presentation_Jan20…

[superzausel]

So nun kann es ja nicht mehr lange dauern. Nur noch Do + Fr

dann muß doch die Bombe platzen, oder?

Gruß und viel Glück uns allen....


SuZau

[kokabara]

Antwort auf Beitrag Nr.: 31.083.892 von superzausel am 08.08.07 18:18:57

Hallo @ all
Gibts schon News ? @ superzausel : wie
kommst du auf auf diesen Termin ?
Mfg koka

[BrauchGeld]

Ist zwar nicht die erwünschte nachricht aber es hätte auch schlimmer kommen können.

FDA says more studies needed for Cipher's acne drug

TORONTO, Aug 13 (Reuters) - Cipher Pharmaceuticals Inc. (DND.TO: Quote, Profile, Research) said on Monday the U.S. Food and Drug Administration concurred with one of its divisions that a further clinical study was needed to demonstrate the safety of its treatment for severe acne, CIP-Isotretinoin.

Cipher said it was reviewing the FDA's response "to determine the most appropriate path forward to achieve approval."

An FDA official had written to Cipher to say the FDA agreed with the view of its Division of Dermatology and Dental Products that further study of the drug was required.

Earlier this year, the company said its new drug application related to CIP-Isotretinion, a formulation of the acne medication isotretinoinis, was approvable subject to two outstanding issues -- a question on chemistry, manufacturing and controls, and a request for additional clinical data.

But Cipher argued that the clinical question raised was "adequately addressed" in its drug submission. This prompted the company to file an appeal with the FDA.

The company has not said when it hopes to launch the product.

[superzausel]

Antwort auf Beitrag Nr.: 31.139.655 von BrauchGeld am 13.08.07 13:55:56

So ne sche... !!!!

Na ja vielleicht kommt ja in den nächsten paar Wochen, Monaten, Jahre...., etwas ???? Nur Spaß, dann warten wir halt noch ein PAAR WOCHEN....



PS. Ich glaube ein Medikament steht noch aus und könnte uns Glück bringen, oder???

@Kokabara

stand in den letzten Berichten, ...within 30 Days .....
Aber ist ja jetzt warscheinlich eh egal....


Gruß SuZau