Again, who cares what Opexa believes? Opexa wants investors to "believe" that the FDA has blessed Tovaxin's continued development. Smart biotech investors who do their fundamental research know that's nonsense. FDA will judge Tovaxin if or when the drug is filed for approval -- not before.
Now, traders don't care about stuff that fundamental-focused people like me care about. Opexa's press release, with "Successful Meetings with FDA" in the headline was more than enough to get the stock moving higher. The stock's low float (just 16 million shares) and historically anemic daily trading volume (70,000 shares) were like dry tinder in a forest fire. Whoosh! By Wednesday's close, 9 million (!!) shares traded hands.
Churn, baby, churn! I see nothing wrong with that, as long as you remember biotech trading is not investing. From my perspective, Tovaxin is no closer to getting approved than it was the day the phase II study failed. "Successful" FDA meetings about phase III studies don't matter.
Via Twitter, @jrock452 asks, "Your take why Amarin raised cash when [it] didn't need it? More leverage for them in buyout discussions?"Rule No. 1 in biotech: Raise money when you can, not when you need to. I still believe the ultimate goal of Amarin's management is to sell the company. Hopefully, having the extra cash on hand helps that happen. More cash or not, Amarin's powerful lipid-lowering drug AMR101 is the big draw.
@crusadernz tweets, "Would you have expected at least some efficacy data to be released after 1st look into phase 3 Stimuvax $ONTY?" On Dec. 22, Oncothyreon (ONTY) filed an 8-K stating an independent data monitoring committee recommended the continuation of the phase III "START" study of Stimuvax in non-small cell lung cancer. This study is being run by Oncothyreon's Stimuvax development partner, the German drug firm Merck KGaA. The "START" study is double blinded and placebo controlled, which means participating patients and doctors do not know who is being treated with Stimuvax or a placebo. As a result, it's not unusual at all for efficacy data to remain blinded and undisclosed during the course of the trial. In fact, that's the way studies like these are supposed to work. Phase III studies like "START" are designed with independent data monitors, who are charged with insuring that patients are not harmed. They're the only people who are supposed to have access to unblinded data until the study is done and ready to be analyzed. Data monitors also can stop studies early if an experimental drug demonstrates a profound benefit for patients. Typically, however, the statistical hurdle is very high for early stoppage due to efficacy, so again, it's not unusual that at the first look, the data monitors recommended the continuation of the Stimuvax study.
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