Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

My opinions on this are not a mystery.

A little confused here so hopefully you can help me and others out. If I read your post right, you are saying that the original priority review SequestOx was a joke and was horribly put together and that NH had as all snow balled???

But now after reformulation it is the best thing since slice bread ?

Feel free to go back and read my posts. I have outright and publicly accused NH of issuing a blatantly false PR when he stated SequestOx was bioequivalent. It was deceptive at best, and that is the most charitable interpretation possible. I've said that I think the FDA was right in issuing the CRL. Not only did SequestOx fail the primary requirement of bioequivalence, but it also sought an ADF label, which imparts on a drug an extra expectation of safety, along with a 5-10X increase in price. I railed against any special food effect label as a drug killer for doctors, and I literally lampooned the farcical idea that the tamper-proof capsules would include instructions to tamper with the capsules in order to sprinkle on apple sauce.


Is reformulated SequestOx the best thing since sliced bread? I doubt that. But it is what I expected SequestOx to be before I learned we had all been misled and until the FDA put a stop to it in July 2016. NH should not have needed two years and a CRL to stop and say, Whoa! What is wrong with our fed tmax? We need to fix that now before we proceed any further. If he had done that, SequestOx would be approved right now. I give him great credit for the idea of getting an ADF oxyIR to approval very quickly, but, with the help of some very expensive advice from Camargo, he managed to screw it up on multiple steps along the way. You are not betraying anyone by recognizing that SequestOx was an awesome idea that was very poorly executed. And yes, I am happy after 3+ years, SequestOx is finally going to be what it was supposed to be from the start.




21 July 2016:


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124039849

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.