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That is the 10-month mark by which FDA has to respond from Dec 22nd filing. We may not find out for a few business days after that in PR. Expecting another one to add under Elite’s label.
Vyvanse has a ton of generics waiting to go into play after the 180-day first filer expires…several months down the road. We’ll be a little late to the party, but it’s a big market and we should fare well.
What they say is one thing, what they do is completely different.
She does not have a 5-year hold timeframe. She pumps and then sells.
She flips all her stocks, not a long term holder.
We have plenty to go on with what’s being worked on. There might be 1-2 more releases prior to next cc. Eager to see sales momentum this Q. Should be getting close to $10M. If we don’t break it this Q, we certainly will the next. Most tailwinds Elite has ever had.
Had me for a second. Stock is not halted.
Got some sweet news coming between now and end of year to tee up next fiscal year. Good times.
There is a ton of best case what if scenarios in that commentary. I’m invested in Tesla and Musk talks out of his butt half the time and continually pushes out target dates (Cyber truck, semi, etc). I’m also invested in VLD, but the projections here are beyond off the wall crazy. The company is inching towards profitability now that initial launches are behind them, but the volume just isn’t there to hit your expectations. Still can’t penetrate market in Europe after 2 years.
How about we start by getting to CFP and stop the dilution? Their execution on profitability has been off by a wild margin from a timing standpoint.
People post for a variety of reasons without financial interest. There are stocks that I follow that I will occasionally post on IH or other platforms for which I do not own or intend to own any position, but still follow the stock.
If you call FDA fantasy, sure. Generic vyvanse just received bioequivalency and should be filed within a month or so. FDA already accepted generic OxyContin filing, but I have less hope to commercialize this one anytime soon. Burel agreement on Adderall ER starting 1/1. I enjoy living in this fantasy as things are finally falling into place. Looking forward to next 12 months of topline and bottom line growth. Will be a fun ride.
There would be minimal impact to Q2 financials that ended 9/30, but could be a tail wind starting Q3. Glad to hear Pyros can finally start moving with commercialization.
About 10 years old, but great paper on brand drug litigation against ANDA mfrs & filers. If Elite gets approval for generic Oxy, sales and distribution may not happen for a while due to legal hurdles. Will be interesting to see what clarity Nasrat provides here as time passes.
https://www.wilmerhale.com/-/media/e318665124fc4d30babd4af5bbb73e7e.pdf
Not difficult to estimate 10 months from filing. Antimetabolite FDA response due next in Feb followed by generic OxyContin barring any hold from Purdue’s legal, which we may see in a legal liability risk footnote of the next next financial filing if not discussed during Q&A.
Lawsuit paved the way to overcome patent issue so generic OxyContin could be filed. This isn’t proof of a filing.
May also get small dopamine agonist approval by then as well.
I expect prior to next cc in Nov this ANDA
will be filed.
Isradipine is already used for hypertension today. Is this exploration of expansion to different population/needs?
I know 401k and similar employer retirement plans often have an option to execute a buy/sell at close. I don’t think that exists for self-directed plans where you can buy individual stocks, but perhaps exists and could be some of volume.
That will require productive “people”.
Nice. Good luck to you with that $10M. Hope that works out.
Schwab? They only get a tiny transaction fee if you trade. What other fees would you pay?
LT capital gains tax maxes out at 20% in US.
$10M revenue or net income? Very different.
Vigabatrin is temporary, not a long-term value add. I’d like to see more product diversification. Lots of opportunity in ER space.
PR was just validation of what we already knew. FDA accepted filing doesn’t equal approval. Here are still some hurdles ahead. If approval is given, this will be a huge win for Elite. I’m expecting really solid growth over the next 2 years based on what we already know, excluding pipeline we don’t have great clarity into.
We don’t have that. It wasn’t accepted and another offer will need to be presented and my guess is that it will need to be higher than before.
Let’s wait for the legal hurdles to pass and FDA approval prior to celebration. There’s always unknowns. Until then we have plenty in the pipeline to keep executing.
Here is wording from Q4 cc on PDUFA date that kicked off for Oxy at time of partial filing or we are so led to believe:
“Once we did the insufflation study, we are resourced because the results were positive and we wanted to make an announcement. But then we learned that there are three other companies that are doing the same thing and we did not want them to beat us to the punch by knowing that we just made an announcement that we're going to file. So we had to be quiet, wait till we file a partial application to get the PDUFA date going, okay? And now I can tell you about it. The full application should be filed by August 1st and hopefully the FDA would accept it. That usually takes 45 to 60 days and once they do, we'll make an announcement. “
Well, we may be dealing with one. The wording for Q2 punts to Q4. Q4 clearly said IF an offer is made and IF it is accepted. Nothing is set in stone. CEO can see everyone’s cards.
Q2 cc
Does Elite now own all of Mikah share of Adderall? No. The Board of Directors actually came up with a plan and an offer, which was acceptable. And then as soon as that happened, we received an official notification from Lannett terminating the agreement, and we decide to go for sales and marketing group. These two variables make things uncertain and we did not want to create MS. So we’re back in offer now and we’ll revisit this issue later on.
Q4 cc
If and when, the Board of Directors decided this time to make an offer. And if it is accepted then there will be an announcement…
What makes you think the same offer price will be accepted by Nasrat?
Take a look at some of the comments and listen to last cc. You’ll realize what it is right away.
We haven’t seen drug name mentioned for recent smaller filings. Might just be waiting for approval to announce to the world.
Back then total market was $2.3B.
Great question, no idea why the ambiguity.
Also, they didn’t file anything today. It’s the acceptance of the Aug filing.
Oxycodone is an opioid analgesic product. OxyContin is a unique distribution of oxycodone.
It has been previously discussed in cc’s that the generic Oxy was held up due to insufflation studies that have now been completed w/ partial filing made mid-year to get PDUFA date going until full application could be filed. I think all filers received CRLs from 2017. All signs point to this being the Oxy filing. Nasrat has mentioned the potential legal hurdles with Purdue and first to file process (probably not us). Don’t think it’s Norco.
*feared