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fred198484

07/27/17 3:05 PM

#28889 RE: Samsa #28887

Selling partnership rights for less is the same as dilution from an equity offering. Either way, shareholders get less.

Also, you refer to the test as a phase III test when what the ADCOM wanted was category 2 and category 3 tests. Category 2 is pharmacokinetic tests which I am sure the FDA and IPCI did not believe were necessary since the drug was bioequivalent to Oxycontin. Category 3 tests are clinical abuse deterrent studies which test whether the proposed deterrents are effective. You will notice the company did not say it would do any Category 2 tests in its PR today, so the FDA must have signalled them this is unnecessary.

One thing I certainly agree with you on is that every aspect of the ADCOM was sloppy. No one really did a great job in the end and the panelists were running around like a dog that had just slipped its leash, paying no attention to what they were supposed to be doing. I am not sure they were ever informed that Rexista had not even had any phase III tests because it was bioequivalent to Oxycontin and since we have this raging opioid problem which has raised the need for drugs like Rexista to get to market quickly. They were all concerned about stigma and insensitivity of the blue dye but there decision yesterday likely cost some lives that would have otherwise have been spared. If it was even only 1 life that was saved it would have been worth approving the drug as there would be no other harm than some blue faces that Rexista would cause. Apparently, hurting an abuser's feelings counted more than saving their life!
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doogdilinger

07/27/17 3:27 PM

#28892 RE: Samsa #28887

sad all the way around. lack of preparation all the way around. even the panelist seemed like they didnt read the packets given to them.



Yep the panel seemed totally oblivious to the 4 points up for consideration as outlined by the FDA themselves lol