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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.
It is the same. Opioid crisis hit. Many doctors moved away from prescribing OxyContin due to the legal risks and ramifications. The market tanked. Plus, we’re seeing other options (e.g., cannabis) to help manage pain.
I think this filing is moot. I think Purdue would have pursued litigation otherwise as they did with Accord if Elite was leading the way.
Elite filed it long ago, but all were dropped due to added insufflation study requirement. All had to complete this and refile.
At end of the day, all will get launched. It’s just a matter of timing of a few months here or there.
I don’t lose sleep over it. To each their own.
That was when we were a contract manufacturer. Margins were slimmer. How times have changed for sure.
This is the same for all the others we recently re-acquired. They are no longer discontinued, but shifted to active status.
What do you mean? Methadone is already listed in Orange book under Elite like Codeine, Perc & Norco, as expected, but will launch in time. I believe it was last to be launched based on last cc.
Facility expansion and equipment are depreciated over life of asset and R&D is expensed in P&L.
I believe he meant yes the incremental $75M was for Norco/Perc/Methadone.
10% was just Vyvanse with shrinking market. Would not have included Concerta. Until we see a BE and filing acceptance let’s not factor that unknown in. Concerta has been a hard nut to crack for manufacturers. This is only way math makes sense.
If Vyvanse is approved and Concerta gets positive BE, that’s all we’ll need to get there and stay there. Plus, we have Perc, Norco and methadone as icing on the cake.
DEA approval should be coming soon, if it hasn’t already been received.
That has to do with the history of Mikah and the ongoing non-arms length relationship. Do your dd and then make up your own mind. I’m not a fan of it and hoping Elite buys out Mikah’s ownership of Adderall soon.
Yes, website has same issue.
Do you only post info from chat GPT?
“Put all your eggs in the one basket and watch that basket.”
- Warren Buffett
Yes, but these aren’t happening very near term. Codeine still has about month to go before launch if they follow 6-8 week path previously communicated. Vigabatrin can likely be scratched from list.
What good news is that? Codeine won’t be launched until mid-October. BE results?
Saw that too. Of course it’s overbought based on historical trading data. It’s backwards looking.
“Although the side effects of the drug are a rarity, study lead author Lauren Moran said doctors who prescribe these stimulants for attention-deficit/hyperactivity disorder should "maybe stay away from (higher) doses, or just make sure that you're carefully monitoring patients."
Nina Kraguljac, a professor of psychiatry and behavioral health at Ohio State University, said the study clarifies that only higher doses of Adderall and other prescription amphetamines are linked to higher risk.
"That is absolutely novel, very clinically relevant and very helpful because it also assures you don't necessarily increase your psychosis risk by taking lower to medium doses," Kraguljac said.
I see ASCM as top Bid & Ask
I thought it was already sold to them as part of the deal and we simply played a temporary role as mfr, if launch took place in time before contract expires.
*Nasrat lol
Voice to text doesn’t like his name.
Master could easily throw in another poison pill
All depends when you bought. Fun to watch for sure. Less than a month away until codeine w/ APAP launch paving way for Percocet & Norco.
Vyvanse will solidify it along with known pipeline we are launching.
Uplisting to an exchange with R/S to clean up O/S with growing revenues and profitable will attract institutional investors. Nasrat would have to go to investor conferences and actually have an outreach/IR strategy, but that comes with the public company territory. It would be an absolutely huge win. Not only do you attract institutional investors, but also index funds.
Fun fact: most shares today are held by passive investment vehicles (indexed funds like Blackrock, Vanguard, etc). Been this way for almost 10 years. How much does Elite get of that today? None.
I am expecting a R/S near term after Vyvanse approval with follow suite of uplist and then acquisition within 2 years.
Come on dude. With a 200 forward multiple? We’re all excited for what’s to come, but no realistic analytics and math will come to a current $7 billion valuation.
I think once Vyvanse is approved, launched and capturing market share we will get there with current known portfolio.
Loving the nice volume in these trading sessions over the past couple of weeks. Eager to see who is buying in.
No, I don’t think so. I don’t think Elite is out of the woods yet. We’re still waiting on FDA anyways before we can move forward.