Post by
Priatoma on Jan 21, 2020 1:34pm
Advisor commitee vote and PDF
After rejection of IPCI oxycodone in 2017 the company fulfill each and every requirments those were asked by FDA. IPCI perforemd catagory 2 and 3 studies moreover anything-anytime FDA asked the company did. We saw the FDA presentation too together with IPCI presentation. Both the presentation were good enough. Advisory commitee vote negetively and said that they do not want opioid drug any more as its abused. I do not think this is good logic against the product. My point is IPCI product is not worst that other products those are now in the market. I would say a bit better than the reference products. So, why should not be approved? Because any research in this world is meaning of development. IPCI developved the product that could not be abbused by injection. So, its better than any other products in the market now. My another point is just for example: If a Toyota car is very good, but no body can assure that will not get accedent. on the other hand Nissan made a car with same specification that also cannot be assured of not get accedent. But, they both got permission to run on road. I think now the matter is upon FDA whether they will permit or not. To me IT WILL NOT logical if they thumb down.
Comment by
Priatoma on Jan 21, 2020 1:37pm
I also think FDA need to act according to Scintific eveluation NOT on emotional basis.
Comment by
bigkagan on Jan 21, 2020 4:07pm
I'm with you - the AdCom people rejected the Aximiris on purely emotional and moralistic grounds but Oxydone is not banned in the US. If FDA doesn't want any more opioid drugs it should have told that to IPCI last year instead of telling them to do more tests. IPCI could sue FDA for dealing in bad faith
Comment by
bigkagan on Jan 22, 2020 5:43pm
FDA only agrees with AdCom in 80% of the cases - so there is no a better candidate than IPCI to be in the 20% when FDA disagrees with the AdCom and I think today's 30% rise in IPCI shows that some investors are beginning to smell that
Comment by
bigkagan on Jan 27, 2020 1:08pm
looks like FDA isn't in a hurry to reject Aximiris, they don't even have a date, usually they have a date called PDUFA but not in this case. If and when they reject Aximiris it will look very bad to reject the only abuse-prevention Oxy drug given the opium epidemic in the US
Comment by
bigkagan on Jan 31, 2020 11:07am
wow, up 10% on a good volume, maybe it's not over yet, ha
Comment by
bigkagan on Feb 03, 2020 3:15pm
how come no lawsuits against IPCI after the AdCom rejection like it was with CORV, maybe lawyers are smelling an FDA approval? hee