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gonna have to wait for the offering too bc so far it's just a shelf registration, NOT AN OFFERING.
Either we're selling off products in anticipation of a merger or we have more profitable products coming or a combination. We were at 18 in November. We've added one and sold a few. Nasrat isn't a fool or clueless.
he must be pretty good if he outcooked the Enron accountants. He's one man compared to an army.
not necessarily. It doesn't take as long to get drugs approved in many other countries. However, the cv is vastly exaggerated.
So who's going to lift this ban?
This is all so overwhelming. There's cooking and writing and presenting. If Carter is cooking the books better than Enron did, does that make Carter the greatest chef of our generation or does that make him the William Shakespeare of CFO's? Nasrat must be the Chuck Norris of CEO's if all the accusations are true.
if the books were misrepresented, doesn't Carter have a professional and possibly a fiduciary responsible to intervene, to clarify, to defend the integrity of the books? He was on the call. He spoke during the call. Isn't he an intricate part of how our books are and were represented? LOL OLO LOL.
are we talking about the "cooked" books or the not "cooked" books?
It's amazing Nasrat can cook those books since he's not even an accountant. The man gets more impressive every hour.
If I didn't want Nasrat in the c-suite, I wouldn't be invested. The day I no longer believe in the leader, is the day I pack up and disappear. But maybe that's just me. lol. lol. lol.
I did. Lol. olo.
yet zero evidence is presented. Enron was busted. Elite hasn't been busted. Carter must be better at this misrepresentation than all those Enron accountants combined. He's quite the master. He must be underpaid.
I don't believe Nasrat said he wouldn't be on the call. he said he wouldn't be giving us updates like he's been doing. Over the years it's been pointed out many times that he tells us more than most ceo's. Everyone is reading it his words just too much.
fair enough. Just know that there is zero chance we get an oncoprex related approval this year. Approval, not acceptance. We'll get an acceptance for an amendment. Zero chance the diabetes therapy gets an approval this year or next. I wish it weren't so, but it is.
Just bc we aren't going to get any approvals doesn't mean we don't have some good catalysts near term, bc we do.
Getting approval with no IND application, no human trials, and no application to market a drug therapy would certainly be a BIG move. Technically, we may have filed an IND for the diabetes therapy by May. But no drug has ever been approved with no phase 1/2 human trials that I know of. Some cancer drugs have been approved halfway through phase 2.
Does anyone know of any drugs that were approved before phase 1? Am I reading this wrong?
I want to hear more about approval in 2 months. Zero human trials. The first approval ever without human trials or an application for approval to market a drug.
there's a great chance but much more likely at least halfway into the tagrisso combo phase 2 if all goes well. By then more will have started and we'll know more about our other work.
here's another pr catalyst coming at some point. This is probably the other IND mentioned in the investor presentation pdf:
Correction: you are mixing up the mono-therapy with the new combo therapy. It seems clear that we think we can get to approval faster with combo therapy.
Geeeez. You are talking about two entirely different drug combo therapies; one was with Tarceva and the other is with Tagrisso. We "pivoted" from combo with Tarceva to a combo with Tagrisso.
Nothing has been leaked. There's no technical or non technical phase 3. Learn something about Fast Track and accelerate Review.
https://www.precisiononcologynews.com/cancer/genprex-focus-developing-immunogene-therapy-start-lung-cancer-trials-year#.Xk7w2Ep7nIU
that is not how it works. It's not Fast track review of a drug application. That is not what Fast track means at all. Unless they aren't going to pr it, we haven't submitted our an amendment to our IND to even start the phase 1 of what we got Fast Track designation for. We cant enroll patients until the FDA formally accepts this amendment or an entirely new IND for this therapy, which we won't do bc we'd have to apply for FT all over again. We are not seeking approval now. We are working on seeking acceptance of our plan for this phase 1/2.
Basically, there is no drug application here to even get an approval for.
the only de facto "phase 3" will be the post-approval studies if the therapy meets its goals. Stage 4 cancer patients don't live long enough to endure phase 3 trials.
there's no "potential skipping" of phase 3. There is no phase 3 in the path we are taking. It's the real reason we reset our focus.
Our path right now is:
fast track designation
amendment to IND/Acceptance (where we are right now)
phase 1/2
accelerated review
post-market studies to confirm
Contact Varner. That would be news to him. Do some more dd to learn what this company is really doing.
This is what we are doing right now for the lung cancer therapy. Could be a near term catalyst. I've seen mention on various boards that we have no news for a long time. Also keep in mind, we are working on 2 IND's.
There's no info. We have no phase 3 and we aren't pursuing any phase 3. It seems clear we are going to do a phase 1 and 2 combo (possibly short phase 2) with oncoprex and osimertinib, and if that goes well, we'll submit an IND application and then apply for accelerated approval, thus bypassing phase 3.
You can't do phase 3 when patients have a very short life expectancy, which is what our therapy deals with. .
do you have a link to verify this phase 3?
what does options expiration have to do with a stock that has no options?
what phase 3?
Just like we went from 1m to 5m a quarter, we'll go from 5m to 10m to 15m and so forth.
That's at least 2 quotes from a man who sounds like he plans to be around for a while. Also sounds like a man who expects to be on a major exchange. Not if but when. He's talked about mergers too much for there not to be some discussions going on.
that great quote of course is from the November 2019 conference call for anyone wondering.
he said in a couple of quarters, not in a couple of months
Lannett already markets products better than anything we have. Nasrat isn't giving our company away, and Lannett has absolutely no need to pay a premium for anything we have. We aren't becoming a part of Lannett, especially not anytime soon.
Transcript link Q3 2020 Earnings Conference Call
https://seekingalpha.com/article/4323198-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q3-2020-results-earnings-call-transcript?part=single
Hellooooooooo!!! We've already beaten his projections
yep. Next cc will be for yearly financials for one. Also, we will have booked revenue for the launch of Adderall ER. That will significantly boost our final quarter revenue. Haahahahaha. lol.
nope. that's an assumption. He probably just doesn't want to get 50 questions every quarter based on those predictions.
If he says we're gonna make 5m in revenues and it's 8m in revenues, he gets blasted. If he predicts 5m and it is 5m, then he gets blasted. It's simply a no win situation.
It also is probably too soon to know the orders. The launch quantities is probably pretty standard. He may know more about predicting revenues after the initial launch. Lannett probably won't know what their customers want until after they send the launch quantities.
There's also the fact that ER is going to be a significant increase and he may not be comfortable jolting everyone with that. ER is a game changer. That means something. Just 3x more than IR is a lot but it could be a lot more than 3x IR.
no way. We'll move up after we get word from Lannette that they've launch ER. That will be pretty big. Traders will love that. We'll pop up and probably fall back some but we won't fall back more than 50 or 60 percent of the spike.
he specifically said we plan to ship launch quantities this quarter, so that implies we haven't shipped them yet. and for those who couldn't listen, he said it multiple times.
his, Nasrat specifically said no forecasts if I understood correctly.
Nasrat said no prediction for future revenue
also shut down talk of ADT development
fully planning to ship ER Adderall launch quantities to Lannette this quarter, doesn't mean Lannette will launch immediately.
(He didn't say but keep in mind we book those revenues when we ship, and that is the standard across all industries)
We got a surpise FDA inspection, No problems found. said this will help with applications/approvals in the future
Also shutting down talk of reverse split
Nasrat said we could sell more IR adderall but Trump admin asked DEA to reduce quotas and that results in us not be able to sell more, even though there's demand.