Re: Has the feeling
Jeff: Actually I don't think the FDA really cares whether they take 6 months or 8 months, 9 months or 10 months. Its an important issue to the company and investors, but not the agency. To them its a job to do. Maybe in communications going forward ACAD can get more information on the choice of review timeline and pass color to us? It has caused consternation whether warranted, so if ACAD knew the reasoning at this point, they would likely have told us something to massage us and the markets IMO! I believe they told us the truth---they don't know and they can ask and pass it on?
I am more interested in commentary from ACAD revealing anything on why their P3 study reported recently had their primary efficacy slip-up and what if anything they will be doing. I suspect they will say for now they are evaluating the results deeper. What are their plans here going forward--do they know yet?
I understand what you mean by an advisory meeting, as it is another material event to play stocks on as some momentum trade and it give insight into a more distinct decision date by doing one, but from my point of view, you would consider an advisory meeting to be like getting corn stuck in your teeth! Not getting one actually soothes me, but your point on decision timing it gets harder to predict when decisions will come down! These panel meetings are real clown shows and who knows what other goofball issues might arise from one by members with agendas? Let the FDA decide on their own me thinks!
Be careful what you wish for! Wasn't not that long ago for company AMRN ontheir drug that there was not going to be a panel meeting for their sNDA on expanded indication and then 5 months into the review, all of a sudden there was one to be scheduled! Agency their mind midstream! Not saying it will happen to us here, but one must consider every possibility! I don't see it, but the FDA does what they want!
On the safety, I agree. It as an issue was misrepresented, was used to depress ACAD stock and work the PPS by markets, but the agency went through the process evaluating it and cleared out all the BS IMO. Over time saw a spike in ACAD PPS and then the drop, and then the spike, and now the drop all related to the news cycle mostly! Now if they don't need a panel meeting, then I doubt the drugs safety record given the indication, is phasing the agency--its a known situation examined already. Look at and how that population of patients are served now. Not pretty IMO!
Always be ready for anything in regulatory reviews and go with the flow if you believe in your drug and company as anything will be used to drive ACAD PPS---real or unreal! I always strive to stick to my overall thesis based on my research unless serious things come up I think myself change it--not some analyst. I trust me and if I lose, I blame me!