Personally I think the market over reacted on Friday.
Lots of good things still to come.
AND Elite will still be meeting with the FDA about SequestOx.
Under Gottlieb labeling may yet be revisited because YES Virginia
the crisis is just that bad. NOBODY has anything close to an answer.... with the exception of Elite Pharmaceuticals. Maybe Lasers is right about this. I have no idea.
Disappointing Tmax results that can easily be rectified with labeling. Well golly gee imagine that!
As for the major Pharmas like Pfizer and Purdue..... they have ZERO
ADF products yet continue to pump out addictive opioids by the ton.....
with the exception of tamper resistant OxyContin. And what a joke that is. A $2.5 billion dollar opioid joke that can be abused quite easily. FDA has made it so that Purdue does not get the total piece of the pie for their formulation. Tamper resistant
just does not cut it anymore. FDA nixed Opana because it too was a joke easily abused. And Endo had the solution according to some who post here. Well, where is this solution now? Down the toilet, that's where.
So the bottom line here is what Elite has in their current pipeline
and what the FDA needs to do with the IR version of Elite's
ADF.
The onus is actually on the FDA. Squarely on their shoulders,
not on Elite's shoulders. Up until now Elite has done everything they could do. If Elite gets approval of this version with a labeling contingency until they can possibly reformulate again, I would say that is a distinct possibility. And if that reformulation fails then Elite has to carry the labeling forward
with what they have. It IS just that simple. No politics, just act and do the right thing. FDA has nothing to lose while buying time for possibly a better formulation for Tmax.
It is a no brainer.
The FDA will have to get creative if they want to truly curtail this epidemic Big Pharma has created and Big Pharma has no answer for. Mr. Gottlieb the ball is in your court. Deal now or wait years with no guarantee of an answer. Labeling revisited, or scrap everything with no IR solution.
I think the answer is very clear here.
