My only glaring question now is why the hell did IPCI not have the category 3 HAP study completed prior to AdCom?
I had initially thought the panel was demanding Phase III clinical trials...but thanks to your great explanation on the 3 categories of human abuse liability studies...I definitely feel that IPCI made a major miss by not having a category 3 HAP study completed and submitted in the AdCom briefing document.
Wasn't Dr. Odidi a scheduled speaker at last falls and this springs Human Abuse Liability & Abuse-Deterrent Formulation conferences prior to him cancelling both of those speaking engagements? How could he have even been a scheduled speaker yet miss the mark so badly on having a category 3 HAP study completed prior to Rexista AdCom?
The only good thing is that IPCI may in fact be able to complete the category 3 HAP study prior to the Sept 25th PDUFA date and still receive FDA tentative approval.
It's time for IPCI mgmt. to seriously consider a major overhaul of how the hell they present their still evolving story to market...the shit has already hit the proverbial fan so to speak...so someone needs to start shaking some sense into Dr. Odidi that it's time for him to focus on the science and bring on some damn professionals who know wtf they're doing when it comes to dealing with the FDA, analysts and the public markets!
IPCI needs to bring in a qualified and experienced bio CEO and a Vice President and Dr Odidi and his wife can head up the science team!
These are the type of mistakes that scientists make and if Dr. Odidi ever expects IPCI to succeed he needs to recognize his faults and step aside!
Him and his wife will still maintain control with their control shares...but now I know why the analysts and institutions have not yet taken to this stock...none of them are happy with the executive mgmt. roster set up!
Fred. ..well then thats the issue...There is a discrepancy here somewhere. ..they mentioned in the meeting about doing human studies..if yiu recall the one panelist was concerned them being done in Jordan. The issue became as I saw it they didn't have completed the tests fir oral and nasal. The reason being that they were not going for that indication yet and could follow up later. ..I believe that will be the basis of litigation as numbers has just pointed out the pr put out by the company suggested that they were going for indication of oral and nasal. Hence the misleading of shareholders claim.
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