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I love how Elite has broadened its pipeline and developed partnerships.
I care about revenue. Oxcontin brings in billion$. Don't get caught up in distractions.
Here are Nasrat's words:
Oxcontin brings in a lot of revenue. Nobody cares what release formula it is.
Thanks, Lasers.
Like I said, where's the proof? Those are just claims, speculation.
Post all that research data. It's all purely speculative. Nothing more than fear mongering to protect profits.
Did you email Nasrat any questions about side deals, ratchet-able options, the nondisclosure of tmax issue, when is enough, enough?
That's all BS. Nasrat has led Elite to 4 ANDA applications filed with the FDA and under review right now and will soon have another in generic OxyContin . That's not sleight of hand. That's not appearance. That's real substance. If anyone has evidence that he's lying about those applications, please present it. Otherwise those applications are real and very serious accomplishments.
So the question remains: how far into the process does the FDA go with the ANDA for which they are withholding approval re: warning letter. Does the FDA go all the way through the process and then just withhold announcing approval or do they stop at some point before that?
BC Big Pharma won't do it without right of first refusal for the others, and as Nasrat said, that's them getting the technology for the price of one.
Yep, I completely agree. Scammed by the FDA and their puppet masters.
SequestOx Program was not stopped. If it had been stopped, Nasrat would not be seeking guidance from the FDA, but let's not let facts get in the way.
Much like an investor investing in company whose leader he or she despises and doesnt trust.
all that yet you assume Nasrat is either lying to us or withholding information or you assume he simply can't comprehend anything he reads. Nasrat stated that the FDA didnt' say anything about the technology. I choose to believe him. That's not an assumption; that's not speculation. Also not sophistry.
I've only got the one Nasrat got. Apparently day trader has a more comprehensive copy that explains how the technology has faults and needs more testing to be proven.
If you were correct then you could easily point to the CRL and the FDA's problems with the technology. The technology isn't the problem. The problem is that the pain killing part of the drug doesn't get into the body's blood stream fast enough to overcome the FDA's antiquated system. Approve the drug and let doctors and patients determine if they want to use it. SequestOx is perfectly safe to use.
No, you are completely missing the point and the question. You failed to point out any complaint from the FDA in the CRL. If there were a problem with the tech, it would have been listed in the CRL. That's how CRLs work. So you are openly stating that the FDA overlooked the technology in their review. To say the tech isn't proven is to say the FDA just ignored the technology. The technology is validated until the FDA says there is a problem with the technology. They had a chance to say something was wrong with the technology; they didn't say anything was wrong. Ergo, the tech is proven regardless of what you say.
How on this earth do you figure Elite will go bankrupt? We aren't anywhere near bankrupt. So you figure Nasrat is thinking "let's file generic Oxycontin and then we'll file for bankruptcy"? I'll file this prediction right there with that other company prediction of $10 buyout minimum when it was at about 25 cents.
If the tech isn't proven, please explain why the tech wasn't mentioned in the CRL. The purpose of a CRL is to cite what needs to be resolved. Does the CRL cite any problems with the tech?
What does this even mean?
Why does the ADT point really matter? The TMax under fatty meal conditions isn't what's causing the epidemic, is it? The abuse is the problem, and SequestOx helps perfectly with that problem. If the instructions aren't good enough for SequestOx, all those other 60+ drugs should be removed immediately from the market.
If you are referring to Elite, their first NDA submission was immediate release. Did you word your statement correctly?
All that is true, but can we be confident that Gottlieb will be involved with SequestOx discussion and decisions? Is SequestOx on his radar, and is SequestOx important enough for him to be involved?
Primarily bc I think no one is going to offer anywhere near the minimum Nasrat would accept for a buyout. I'm sure there have been lowball offers for the technology, but no companies are going to want the generics we have right now, nor is BP going to offer Nasrat so much he can't refuse to sell the technolgy. There is also the reality that BP isn't as interested in the technology as many assume they are. There's no near term threat to BP's opioid profits; therefore they have no concern for urgency.
There may be a few companies interested in buying the upcoming ANDAs but not before they get approval.
Nasrat has made the plan pretty clear, and it's a long term plan. It's mind-boggling that so many investors refuse to see it or accept it. They're consumed by hope that Elite will be sold. There's just very little sign that could happen. Anyone holding out for a buyout should move on or come to terms with this being a long term investment.
Everybody on this board knows if American Big Pharma had this it would have been approved long ago and no Phase 3 trial would have been required.
I think there is 0 chance Elite gets sold anytime soon. However, there is a serious chance the Sequest technology could be sold dependent on the next FDA meeting.
No, it is definitely not semantics. You've locked into it meaning something it simply doesn't mean. The study that was ongoing was completed.
There were other studies planned if this previous study went as hoped. You asked why was "the study" halted. It wasn't halted. The study was completed. The info from the company doesn't say anything about a study being halted. That is a fact. The overall plan can be said to be halted. That is a significant difference.
Except once again your information is wrong. Nasrat has not thrown in the towel nor given up. He has paused the trials until getting guidance from the FDA. If he had thrown in the towel, he would not seek guidance from the FDA.
SequestOx is NOT DEAD. SequestOx is NOT DEAD.
Why good riddance? SequestOx is a great product that can help people. Why do you want to see it gone?
That's utter bs. Nasrat has said so, and testimony is considered evidence. You can believe it or not; it is still evidence. Also, the FDA has not denied that they originally said it was a labeling issue.
Why does anyone think the pr for filing this generic will matter? Do you consider that filing to be a catalyst? We would still be over a year from getting it to market.
Only serious responses please.
This is not going to zero. Get a grip. It was borderline bankrupt a few years ago and wasn't zero.