Sunday, October 06, 2024 11:35:54 AM
But we all have to admit that Nasrat did not openly tell us everything going on that he could have with respect to SequestOx. On the other hand he clearly qualified what was considered BE in the PR to "The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. ". So he wasn't exactly not mentioning the problem.
Everyone reading it (especially all the doctors and pharmacologists) could/should have noticed this unusual qualification and caught on that something wasn't right. Anyone professionally trained who doesn't admit and recognize they had ever opportunity to catch the issue, or at least know something was up is being blinded by ego and not taking responsibility for their failure. If you review recent BEs none of them qualify what component of the testing passed. I also recall discussions in CCs prior to the CRL that I was kicking myself for not realizing they indicated to something not going as usual for SequestOx. He was at one point told by FDA that having verbage about avoiding some foods when taking the product (to avoid affecting absorption). I have taken drugs with those directions so it isn't a shock that we all thought that was acceptable.
Nasrat isn't the only CEO who carefully threads the line between omission, misleading, and lying. CEOs like politicians do that as a matter of performing their jobs. Our job is to not be mislead. Lets all remember there was a $2million dollar pay day for Elite for simply submitting SequestOx for review. If he had decided not to submit and shelved the product because it was absorbed at a different rate when taken with food the company may not be here today. I think that was the amount...might have been 1 million for the submission and 1 million for the BE, don't care to look it up.
So to answer your question we benefited from Nasrat's not so clear communication.
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