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I see today’s daily volume at 1.8M
I could be misremembering, but I believe Nasrat stated we are using some of that tech in today’s products.
I wouldn’t even ask. When there is a material event, we will know. You wouldn’t divulge that publicly from a strategic standpoint.
We do know that Vyvanse market will take a big hit and same with generic oxy if we get that too. They will still be good markets, especially Vyvanse, but same song and dance as you shift from brand to generic.
There’s a similar quote about stakeholders. Shareholders has management by the throat, but debt holders have management by their balls.
Could be this week, could be closer to Halloween. This is first opioid launch so I could see it take longer to ensure they have it right for Perc & Norco, which are the bigger fish to fry. Learn what we can now with Codeine to avoid mistakes that would multiple in magnitude for those two launches.
It’s been 13 months since Elite has received the last update from R&D regarding a positive bioequivalence study, which was for Vyvanse (expected near term approval).
Elite has spent $8M on R&D over the past 12 months. I’d love to see a couple positive bioequivalent studies in short succession. Been radio silent since Aug 2023 with lots of spend.
The known launches and pending FDA approvals will keep Elite plenty busy for the next 6-9 months.
I think quota has been only thing holding them back as of last cc. Codeine w/ APAP launch likely over next couple weeks.
Look at last cc script. Methotrexate just launched in August and last cc the CEO laid out a timeline for the sequential launches.
100% agree that it would be temporary. No telling what fed gov will do/not do these days. Would be good to keep ports open and goods flowing. Prices still aren’t normalized after last supply chain debacle.
Yes, but air freight costs an arm and a leg.
Got to be foreign otherwise FDA wouldn’t need to dig further and extend approval decision. Hoping it swings in our favor. Counting on this one moving forward to keep big momentum going.
You are right to question this. I was confusing BE testing locations vs API sources.
Elite could also be impacted by this. Our API comes from India.
I don’t think all of those can roll out by year end. I’d expect Codeine w/ APAP soon + Percocet by year end.
If we get Vyvanse approval that will slide in as top priority. All others will wait until next calendar year to launch. Hoping we can launch Perc and Norco this fiscal year by end of March. I think Methadone won’t be launched until fiscal Q1.
I can’t imagine that deal going through. It just pushes more litigation and accountability for the owners’ wrongdoing.
Also a sad side note is some of the money that states have received from these opioid lawsuits is going towards other things, which I personally think is wrong. If there was a judgment for a certain reason - put the funds toward that specific cause.
How would Purdue have any leverage in striking a deal with Elite if patent case ends in Accord’s favor?
Help me understand why Elite would want to partner with Purdue vs going alone?
Just looking into opening a position. Why aren’t any of 2024 results printed? Buyback is taking place, but investors can’t see any recent financial progress to determine same outcome for themselves. I’m in early DD stage, but eager to dive in to more data and insights as time permits.
I think that’s how I came across ELTP was a Scottrade screener back in the day. Lodrane and SequestOx nearly made Elite disappear of the map.
How is that? The ID was just created today.
I believe there are 2 cases against Accord. This is one of them.
Doubt it, but will keep heading north.
It’s anyone’s guess how close they are to max mfg output & storage capacity. Sounds like we still have little ways to go for FDA sign off. Their drugs are in high demand so I would think that could prevent storage challenges. We can always add more shifts or extend shifts for to increase mfg and packaging.
Will new facility lead to ability to increase API allocations from DEA?
We’re likely more than half way to next product launch, codeine with APAP. Should see PR within next few weeks. 4 weeks have passed since Methotrexate launch. Looking forward to this opening up Perc & Norco launches.
There are no insider sales.
I think if Vyvanse is approved it will be worth $1 by itself over time, but not right away. Hoping we get that approval soon without delays. Would be absolutely huge.
Agreed. I also think Concerta would be huge. Would be nice to see a positive BE trial soon.
That’s crazy. I figured there would be a T+2 settlement wait period, but that’s like 2 weeks.
Yes. That’s where you’ll also get sell-side analyst coverage at real investment firms beyond the Zack’s coverage we have today. A couple of analysts can go a long way in getting exposure to investment community, plus passive funds (majority of investment funds today) can buy in once on NASDAQ.
It’s not approved yet, that wasn’t the point.
*Accord
According to has had slaps on the wrist, but I wouldn’t expect it to impact their priority. Accord has received FDA approval as recently as April:
https://www.pharmaceutical-technology.com/news/accord-biopharma-hercessi-approval/#:~:text=Accord%20BioPharma%2C%20the%20speciality%20division,to%20treat%20HER2%2Doverexpressing%20cancers.
Volume drying up. More sellers. Not a surprise. The long game is clear and we have good indications how this will end.
Question for group. Based on last cc, FDA needed another month to review API source for Vyvanse. Do you think that is another month from GDUFA date or about month from that conversation, which would mean about now?
Roth IRA you pay taxes up front and not at withdrawal.
Absolutely. Vyvanse may get delayed. OxyContin may get kicked down road for several years. We do know for certain what will be launching over next several months - that alone is a huge win. We haven’t seen any new positive BE trial for a while - lots of R&D being spent. Would love to see a couple in quick succession hit the wire.
Elite held the session in green territory, but volume is softening. It’s just a game of timing for what’s to come - facility approval, launches, BE studies, FDA approvals, etc. All good things, all good things.
For my calcs, I’m using a lower flow through of 20%. I expect this to increase with Vyvanse and newer drugs that recently roll to generic.
We’d also be excluding any R&D pipeline, positive BE, IP, etc.
We aren’t even close to the 1st or 2nd with Adderall IR and ER, but we’re doing just fine. Being an earlier player has earlier mover advantages to capture market share vs brand. We are developing a great brand with high quality and fair price (not lowest), but we are small and nimble, which brings the ability to pivot quickly in the market.