Personally I believe it will be accepted for filing this time. They took more time from the completion of collecting data to submitting the NDA and they have significantly more money due to their other investments. Hopefully this translates to being more careful and getting it right.
In my opinion (and that is all it is) the NDA being accepted will be a healthy pop. It will generate some interest...but the PPS will fall back a little, as expected.
Then the FDA meeting regarding 514 will hit and the PR from that will again provide a healthy pop.
Then the 514 NDA would be submitted - which, after a meeting and after the 530 being accepted *should* be a slam dunk to get accepted.
A few months later we should be looking for a 530 approval.
I believe they will be bought out after a 530 approval but before a 514 approval - since the emulsion process is the same and should prove to be repeatable, but the market for 514 is easily 10x that of 530.
There will be a LOT of daily fluctuation as traders play this - but if you are willing to hold until the end of the year I feel the payoff will be very nice.
I know that there have been some negatives in the last year (RFT letter, RS and dilution to raise capital). The RTF letter was inexperience/stupidity on the CEO's part or maybe the FDA really did change their rules...who knows. The RS was a decent move for the company to give the PPS some legitimacy in the market - but it was bad for existing stockholders. Tough call...if I were the CEO....would I have done the same? Probably. The dilution to raise capital was, in my opinion, a very good thing. They now have no pressure to force things - and can take the time to get it right.
Who knows...I am back in and unless Brian just finds a way to absolutely screw us, I am holding through 2011.
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