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Replies to post #240119 on Elite Pharmaceuticals Inc (ELTP)
But given today's news, (that I don't feel was "bad" at all), did, however, raise the specter that we had all seemed to discount: a total re-formulation of the oxy portion of the capsule bead. When the CRL was received, having to reformulate (as opposed to say sprinkle/applesauce etc) was almost universally viewed as the worst-case scenario by those commenting at the time; the hopes were for a quicker test(s) to measure and address the Tmax, not full reformulation.
Dead Drug Walking. Kill Zombie SequestOx.
This drug has been dead since 2014. If not dead, it is severely wounded. Somebody should put it down and out of its misery since Nasrat cannot bring himself to do it. The upcoming meeting with the FDA should not be about some bullshit apple sauce trial. Rather, they should convince (beg) the FDA to allow for a re-submission with a reformulated oxy bead. The naltrexone bead stays the exact same, and its safety and effectiveness have been proven in the HAL studies and the two Phase 3 studies- bunionectomy and methadone withdrawal. Those studies stand valid as proof of the naltrexone bead. Re-do the oxy bead, get it right, redo pivotal bioequivalence, get approval with a clean label, and proceed on with an awesome product that doctors will feel comfortable prescribing.
Do the right thing, Nasrat. This is our flagship and you're going to encumber it with a bullshit label? Fix it now. You've already doubled-down on this zombie bead- don't waste more time and money on it. A new bead and a new pivotal bioequivalence wouldn't take much longer or cost much more than your apple sauce escapades. It is not too late to make this right.
AI
