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Agreed. More time waiting, per usual. It does sound like they'll eventually do well with all the pending generics, but as Nasrat pointed out, they need that stupid warning letter officially cleared before those approvals can start rolling in. Will hold and be waiting in the wings in case we drop to levels not seen in several years.
Agree. Did kinda sound like they wanted to shift the focus off of Sox but it's good that several larger generic drugs and markets will be in the mix.
I would hope the followup meeting has at least been scheduled. I agree, almost certainly haven't already met with them or have specific Sox guidance for us yet.
Thanks Gman. This is definitely a question I want an answer to. That, and when will Elite be able to meet with the FDA to discuss next steps on SequestOx!
"6.Why did ELTP decide to give SunGen 50% of our ER ADF line in the "mutual" partnership to bring other (unstated) generic drugs to market?"
I never heard that. Are you sure that's the case? I was under the impression that they partnered with SunGen on additional, likely non-ADT generics such as beta blockers.
Yeah, will definitely be interesting to see how it goes. We do know that Inspiron's drug was not BE and was still approved, albeit without full ADT labeling. Need to see what the FDA says on reevaluation of all the data. Unfortunately, the FDA sucks so it'll probably be awhile before we can meet with them about it.
Not so sure about this. Filing a generic OxyContin ADT will be huge. Massive market with few competitors, if any. Others like Percocet and Norco generics, once approved and launched, *should* be solid money makers.
Do agree that they need to prove the tech with an approval, both on the IR and ER sides.
Agreed. Need to hear what the FDA says. Generic ADT OxyContin filing needs to happen soon as well as approval and launch of Percocet.
It is possible. Look at Inspiron's IR drug. Not BE and still approved.
Agreed. Need generics more than ever at this point. At least big ones will start getting approved soon.
None of those were even started a decade ago so...
Definitely agree. Given upcoming planned catalysts and pipelines, this better be the last LPC agreement and Elite should be humming on 10s of millions if not 100s of millions by 4 years' time.
I must've missed that part. What was said?
The FDA is always the question mark. I'm actually optimistic about this new commissioner after the Opana verdict. Put out shitty drugs and they'll be pulled. We already know SequestOx has excellent HAL data, just need to meet the TMax requirement and we should be good.
First one we've ever had inside a trial. He already said dosing is complete. Now it's just compiling results.
Was definitely a good call.
Yep, generic OxyContin filing coming "this quarter".
Either in next 2 weeks or within 3 months we should see that filing.
Right. So I take that to mean anything AFTER October 2016 will have the 10 month timeline and anything prior will have 12-15 months?
I certainly hope you are right... but when did the FDA change the goal to 10 months? Really seem to remember them saying that after Percocet had already been filed, leading me to believe we're looking at around 12 months. I'd love to be wrong. Can you post links and dates to prove your theory?
New FDA commissioner's words are speculation? News to me.
I filed one to try and get the minutes from the December meeting between Elite-FDA. After several months, it was denied.
ELTP accumulation continues, I see. LOL.
Not me. Wouldn't ever put all my money in any one thing, ELTP included.
Photo evidence isn't real huh? News to me. LOL
Nah not in "most cases" lol. The supposed super traders would've retired long ago if that was true.
I've seen evidence of ELTP premarket trades and taken screenshots. Retail may not be able to place those trades but someone can.
A 200% gain is a 200% gain. What difference does it make if it came from ELTP or the S&P? Lol.
I mean.. the average S&P return over time is what, 10%?
Yeah, I'd say 200% is pretty good.
If 200+% is screwing me then have at it. LOL.
And I thought selling out too early was bad. Not being able to count to 3 definitely takes the cake!
Patent final approval is an expense? Okay, maybe a couple/few hundred to wrap everything up. Get LPC on the horn!!!! LOL.
Also:
"Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma(?), **Dr. Reddy’s Laboratories** and Valeant Pharmaceuticals International."
Prior to yesterday's and today's PRs:
"Elite currently has eight commercial products being sold"
Since yesterday's and today's PRs:
"Elite currently has nine commercial products being sold"
Confirmation that Trimipramine is now actively on the market for Elite.
I hope you are correct JJ! If so, approval should be VERY soon.