What should we expect. A sell off because of the CRL or little reaction and perhaps a pop based on the conclusion the drug will be approved once the facility issues are resolved. It is conceivable that the company has resolved the issues and the FDA is simply waiting on a report from an inspector.
Absolutely there will be a sell off. Third Party Manufacturing issues is an automatic Class II. That means the FDA will push the PDUFA date out 6 months. Even if it does come earlier, it won't be like a Class I which would be three months. The FDA are crooks. It will cost Impax $1 million to resubmit. They did the same thing to NAVB.
there is no way the stock will go up tomorrow. The data regarding this drug is great and that was previously known will not change. The issue surrounds manufacturing at the Hayward facility. The company is also trying to remove this facility from the approval process(it was a backup manufacturing facility) to expedite things
In all likelihood, initially the stock will drop with stop losses being taken out and than a bounce back with the hope it comes back close to where it now stands. Perhaps before the open tomorrow the company can offer something positive to instill some confidence in an approval. It is quite unfortunate that a drug that can really help some people is being delayed because the company couldnt get their facility in adequate condition. They should have a conference call on this and provide some answers.
It would appear that the FDA is now in the position of holding up patient access to an approvable and valuable medication. To the extent that resolution of the Hayward issue has been due to FDA foot-dragging, that may change given what is now at stake for Parkinson sufferers. Or perhaps Impax can come up with a way to get its alternate strategy reviewed and approved. Either way, it seems to be a question of "when" and not "if" Rytary is approved. And there is no deadline, meaning approval can come at any time without warning. If you are not long when it happens, you will miss a pop of several $$ IMO. I see a diminished downside risk, and a stronger argument for being long. I would be very surprised to see any real selloff in the stock tomorrow.