SOMX. researching past approvals pasted/link from a yahoo board poster.
FDA Approval chances for Silenor are 99.9% 25-Feb-10 10:29 pm From 2003 till the end of 2009 there were about 430 Class 1 and Class 2 resubmissions. According my research only 2% were Class 1 and 100% of these were approved!!!!!!!!! Many pharmaceutical companies tried to get a Class 1 resubmission treatment but only a few succeeded! The review time for ADLR’s Entereg was extended beyond 2 months because of some “Risk management issues” In my former search I missed the NDA’s that were subject to a Class 1 Response Letter which also leads to a Class 1 Resubmission.
Company Product Class 1 Resubmission date FDA decision Outcome date BMRN Aldurazyme 28 Jan 2003 approved 30 April 2003 CLGY Cellegesic 5 May 2005 Approved 7 July 2006 INSM iPLEX 12 Oct 2005 approved 12 DEC 2005 ALKS Vivitrol 17 Febr 2006 Approved 13 April 2006 SHPGY Daytrana 29 Febr 2006 Approved 7 April 2006 ADLR Entereg 8 Febr 2008 Approved 22 May 2008 JAZZ LUVOX 28 Dec 2008 approved 28 Feb 2009 AMAG Ferumoxytol 12 May 2009 Approved 29 June 2009 SPPI Zevalin 20 July 2009 Approved 4 September 2009
Class 1 resubmissions have a required FDA turn-around time of two months. This suggests there is simply a paperwork problem with the application, some manufacturing details to be worked out, or some simple additional analysis of an existing clinical trial needed before full approval is granted. A caution: simply knowing it is a Class 1 resubmission is not enough. The smart biotech investors will want to verify exactly what is needed – especially if there are new trials to be run.
For Silenor, the form 8K of 22 January clearly states: “No additional safety or efficacy data was required to be included in the resubmission”.
Below please find once more the results of my study.
Specifically for THELIN, I saw that case during my study. THELIN hasn't been denied and is still on the way to approval. If they would have executed the request of FDA timely than approval would have been granted. Pfizer will now follow-up on the FDA's request: "Pfizer says it is planning a late-stage trial of Thelin in the United States in an effort to obtain approval for the drug by the FDA. The day before the acquisition was announced, biotech analyst Andrew Fein of New York equity research firm Collins Stewart LLC upgraded Encysive to "buy" with a target price of $3 per share after attending the World Symposium on Pulmonary Hypertension. "We were surprised by the seeming positivity of European physician sentiment on Thelin," Fein wrote in his Feb. 19 report. Fein also believes Thelin will eventually get U.S. approval. "While U.S. physician sentiment remains split and the sour taste of the FDA debacle has yet to dissipate, the widespread view -- ours included -- is that if one properly executed trial is run, Thelin will eventually garner U.S. approval," Fein wrote. "Thelin is, in our opinion, only one successful trial away from U.S. approval." ref http://www.bizjournals.com/houston/stori...
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