February 12, 2014 8:00 AM Ventrus Biosciences Announces Results From Second Pivotal Phase 3 Trial of Diltiazem Cream (VEN 307) in Patients With Anal Fissure - http://finance.yahoo.com/news/ventrus-biosciences-announces-results-second-130000200.html In the first pivotal Phase 3 trial, the diltiazem 2% treatment arm demonstrated a statistically significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation.
Based on these results, Ventrus will request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the Phase 3 diltiazem study, as well as steps to move forward toward a New Drug Application (NDA). Because diltiazem is approved in oral formulations for the treatment of angina and high blood pressure, it is eligible for the FDA's 505(b)2 registration pathway. The Company is also preparing to initiate a second pivotal Phase 3 study of VEN 307 in anal fissures in the second half of 2012.
Should be an interesting FDA meeting - stock is beaten down and I think any positive news at all will give it a nice price rise - If they ask for more pivotal trials, the stock might sell off? If its found a bottom... then the r/r might be skewed upwards... worse case we dont sell off as we already found bottom... and anything positive pops it!
With the failed second pivotal phase 3 study and the stock dropping from $4 to $1 - Fundamentally on a scale of 1-10 we sitting real low at 2/3 or so but anything positive from fda meeting and we could be going from 2/3 to 6/7!
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