BioDelivery Science's Long and Worrying FDA Approval Delay

Another week has gone by without word from the FDA regarding the approval of BioDelivery Sciences' (BDSI) Onsolis. It has been over two weeks now since the FDA informed the company of a minor delay; a delay in which they decided against issuing an official extension letter. Since the delay, many BDSI insiders have sold, prompting investors to speculate that the FDA will once again refuse approval of Onsolis.

The insider sales alone do not scare me, because if these insiders were selling based on their knowledge of a pending negative event it would be a blatant case of insider trading and they would be facing lawsuits and legalities after the fact.

That being said, the length of time that the FDA is taking on issuing an approval has me a bit worried. A 'minor' delay is a couple of weeks, in my opinion, and a wait longer than that should have been accompanied with an extension letter.

Based on previous sell orders, where I sold some shares of BDSI that had already tripled, I'm already playing on house money with this one, and if we don't hear news from the FDA early this week, I will most likely sell more shares. It's no secret that the FDA can be an inept and unpredictable bunch of regulators, and the administration's most recent action regarding the Onsolis approval is proof of that fact.

A spike to twelve dollars is the high end of my post-approval estimate, but if the wait for a decision goes on much longer, I won't be around to see it.

Proceed with caution on this one and definitely realize some gains, if you haven't already.

It could very well be that once I hit 'Publish Post' news will be released making this post a moot point, but I'm getting tired of the wait.

Disclosure: VFC is long BDSI.