Agreed. Not a fan of antipsychotics for sleep. That said quetiapine is used often though would be used less if not generic. The only way pimavanserin will be used is if they do a specific sleep study in elderly and get an indication. Could happen. But it's all gravy at this point.
With approval. Most of the decline is not specific to the stock. We are closer to buying more than selling. Hold on. Be patient and if possible, buy more on the way back up.
All will be fine with approval. In the long run oil has no impact on the IBB. In the short run it causes acad and other real biotechs to go on sale. When people return to the group - and they always return - they will want to own a name like ACAD. The earnings Pima should throw off is significant to this company.
What is delaying the trial is that ACAD needs to get approval of PDP first. No additional data that could even possibly cast doubt on the PDP indication should result before PDP approval. I never thought they should have started that study when they did. Uli and the gang should have been working overtime to file the NDA instead. Dang. We should be on the market right now with a $75 stock...
The FDA calls an advisory committee then they need help interpreting the data. So they call in a panel of experts to help answer any questions they have. Calling an AdCom seems like a complete waste of time in this instance.
Are you pulling a Budd Foxx and following them around on your motorcycle?
Sure - typically the FDA requires 2 positive (statistically significant efficacy) phase III studies for approval. With ACAD the FDA waived the need to a second study and felt that the results of the first Phase III study were robust enough that they could file the NDA. Then the received breakthrough designation months later. The data are pretty straightforward and support approval. No need for an advisory panel in my opinion.
I think - and I could be wrong - that with Julian Baker on the board, the Baker brothers are more restricted regarding when they can sell their massive ACAD position. What I think this does do if that is the case is make it so that they only way they can unwind the position is through a sale of the company. That of course could be like 5 years from now but much like PCYC and GEVA before it, this asset is a goner
The current valuation would be more than justifiable based on peak sales of about $1B annually. Think about what that would mean in terms of EPS to ACAD. It would be huge. I think a 3x times peak sales is a good gauge going forward. So say most of PDP is in the stock, you are getting all other indications essentially for free. Not cheap, but not terrible either based on this valuation technique