I believe Zohydro will get approved. If the FDA didn't approve drugs based on abuse potential, then no drug company on Earth would even develop C-IIs through C-Vs... Since pure hydrocodone products are already classified at the highest level as C-IIs, I don't think you can claim it won't get approved based on abuse potential unless the FDA is going to restructure it's whole classification system.
Sentiment: Buy
And to add to your point...based on the clinical results Zohydro IS SAFE AND EFFECTIVE REGARDLESS OF WHETHER IT WILL BE ABUSED OR NOT. DRUG ABUSE AND MISUSE IS NOT PREVENTABLE EVEN WITH TAMPER RESISTANT TECHNOLOGY AND FORMULATIONS.
Drug abusers have proven this time and time again.
Sentiment: Strong Buy
If it was safe and effective, Abbot Labs would have made an extended release Vicodin years ago
Sentiment: Sell
And hey, if you're going to be a drug addict, might as well have a healthy liver!
Do u own any shares? If so, are you willing to hold thu FDA decision? I got some shares and still a toss up if i should sell or hold.
Yes I have about 3000 shares. Not a huge investment, I know, but also not a huge loss if it goes down by 50%. The way I see it, I can either lose about $1500-$2000 if its not approved and I sell instantly or stand to make about $8000 if its approved. So a $1500 risk to make 7 or 8K is a pretty good bet. Also, if you can hold long enough past the approval date, some Relday news is bound to help ZGNX recover to the $1.50 neighborhood even if Zohydro gets denied. I feel its about a 65% chance of getting approved and 35% chance they want more studies or some issue with tamper resistance gets it blocked. I'm holding ALL my shares past the PDUFA date and may buy another 1000 to 2000 shares if it goes below 1.38 over the next two weeks. GOOD LUCK!!!!
Sentiment: Strong Buy
I think the smart way to go is sell 1/2 and hold 1/2.
Sentiment: Strong Buy