Mulac,you have raised two points:Pushing the FDAInformation...

Mulac,
you have raised two points:

Pushing the FDA
Information flow

FDA: Unfortunately all Pharma companies are at the whim of this regulatory body and their future profitability is dependent upon it, it is one of the major risks with pharma, but it is a known. All Pharma companies are frustrated with the FDA and timelines, as are the FDA themselves and the lack of funding provided to speed up the timelines.

The dumbest thing a Pharma can do is get on the wrong side of the FDA, you will end up in the longest of queues. It is a very delicate game that has to be played and not a fight to engage in. Whenever a Pharma executive is asked the question about the FDA in public extreme diplomacy is the response, privately they are all annoyed and frustrated but their hands are tied.

Information Flow: The completion of the pre-approval inspection has been communicated as have "potential" timelines for approval. What else can they add other than add to the speculation which is a concern of yours. Nothing annoys the investment community more than trivial or non informative market releases to get attention, that is one of the best ways for a company to lose credibility.

You just have to wait, or sell, it's up to you.