I bet you ZGNX shares go down on this earnings release. Of course the shares will rise when/if they get approval. I am inclined to believe that this delay makes approval less likely.
If they planned a rejection this would have happened. They are apparently working REMS and labeling. I have to wonder if FDA will also change the DEA class to II from III? I'm still holding long and believe approval is likely more than before. I bet analyst reaffirm outperform, perform, and buy ratings in the next week and I see shares rising or being stable.
David: In my mind I do not see how the fda will change hydrocodone to Shedule II. I live int he dfw area and no doctors write schedule ii narcotics except for pain doctors and there would not be enough pain doctors int he area to see all the patients that just need hydrocodone. You would have to have thousands of pain docs to see all the patients. And hospitals what would they do? They dont write schedule II either. SO what would ER Rooms do too? You break your leg and have to go to pain doctor just to get a 30 count hydrocodone prescription? We are not ready for this yet. I would love to know your take on this
Sentiment: Strong Buy
The most disconcerting thing I heard on the call is that no labelling discussions have been had with the FDA. None. REMS discussion yes. Labelling no. That is something that would need to happen if this were to be approved anytime soon.
Honestly David I don't see how a delay sometime into the summer can be positive. I don't know if it's negative either. The point is....who knows? Do you recall the day the SP zoomed up because everyone said how a "brief" delay was so positive. Would everyone have celebrated if they said many months, sometime this summer? There are articles showing how short delays of weeks were mostly positive for approval, but when it becomes a normal 3 month or longer delay, along with negative Adcoms, then not so positive. Also I find it disconcerting that the reason for the delay is the FDA has more issues on opiods to study and rule on. Zogenix was also "disappointed" according to the statements. Disappointment is not positive.
No offense but that is crazy. A REMS and labeling delay would have been communicated during pre-approval communications. They are waiting to clean up Oxecta and Opana abuse deterrent labeling before killing Zohydro.
Not just to play Devil's advocate but I beg to differ. I think the delat can be seen as nothing but negative. If they are going to approve the drug they would already have done that on March 1st. Even 'if' it gets approved after the delay it will most likely come with added restrictions of some sort. I think the delay is so the FDA can deal restrictively with other drugs so that when they get to ZGNX it is natural to do the same thing and doesn't look like they just denied a drug based on it's addictiveness. I admire the 'set of Balls' many here have in continuing to buy this stock (if in fact they are) though. Best of luck.
I agree, the fda needs the cover to deny or issue a CRL. At this point they don't have it and it would be tough to substantiate denial other than political pressure. They need a legal or regulatory resolution here first.