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Per a note I got this morning, he got the boot from the board this morning. Sounds like Dianne made a complaint to Shelly and was enacted this morning.
He said he did execute a good buy yesterday. Good timing for him.
Momentum is now finally in our court with an approval. Gap can fill, but who cares about ST technicals unless you trade. The company finally has solid fundamental validity to one of its strategic buckets.
As Trump would say, “This is yuuuuge!”
Weezuhl corrected me on this last week. APAP is a deterrent, but not ADT. Norco will have the same.
SequestOx tech is our ADF line for IR & ER.
Historically, with this stock the volume drops and so does the stock price. Elite has become a show-me stock that has occasional pops, but consistently falls back. This is history.
The story is changing, but sales and true profitability while continuing to invest in R&D & mitigation of cash burn is what will give investors more trust in this stock and move it permanently to new heights. This is a fresh new inning in a long game.
May 1M+ volume days forever be the new norm.
There has been occasional chatter on undisclosed being Methadone. It fits the market size and makes sense since Elite already manufactured it on a contract basis. We’ll probably hear about that one next.
Depends on the chosen partner and how quickly we can move from approval to launch.
Norco & Methadone may also be approved in ‘18. This was much sooner than I think anyone had expected. He thought Perc would have been 1st to be approved in Q3 call, but was hush about it during Q4 call. Oxycodone will have an uphill battle. Other generic approvals will help financially prepare for that long legal battle.
Well well well. Now that is news that will keep Elite chugging along. Generic bucket confirmed!
Sungen & ADF buckets still TBD with good odds. With much pain & frustration & few missed field goals, Nasrat was finally able to pull a solid approval off. This is huge for Elite. Been a long time coming.
Congrats to all longs.
Lol Apples to oranges. Fortune 500 are solid businesses. Elite’s Methadone contract being eliminated has significantly impacted revenues. One small and simple contract. *poof*
Fortune 500. Lol
Nasrat thought SequestOx was a slam dunk. Oh how times have changed.
How do you think many of those prescriptions have found their way to the streets? Overprescribing to the wrong patients.
Or just 1 10 mg pill. No need to double volume.
That would be a 2 month supply, but confirms same 3-month pricing of $60 mentioned earlier. :)
Far cry from $1,200/yr.
There is a misunderstanding. You can find a 3-month supply of Isradipine for $60, if not cheaper. That is retail cost to patient. Doesn’t factor in costs and marketing split.
No it doesn't. Where did you see that? That is a multiple of the average annual cost.
Big assumption that Elite already has half the Isradipine market.
Or 4 or 5 competitors...
What’s to say they haven’t already begun the process?
That means very little. IF the study does do well, it will attract deep pockets that have many more resources to utilize.
Just because others have discontinued the manufacture of isradipine, it doesn’t mean that will be the case if the results are positive for PD. In fact, it won’t be.
That is all I could ascertain as well. Often times organizations release initial high level study results. Do we get an early read or wait with baited breath until end of ‘19?
Has the interim analysis been published? Here was the initial plan for the PIII Isradipine study for PD:
"Interim analyses
An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5454402/
Has the interim analysis been published? Here was the initial plan for the PIII Isradipine study for PD:
"Interim analyses
An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5454402/
Theranos also failed to allow peer review. Elite’s products aren’t new drugs, but a different route. Holmes started with a lie in hopes that the millions in R&D would lead that dream to a reality. It didn’t other than tinkering with competitor’s technology.
Hasn’t failed quite yet as the FDA is the ruling body. FDA approval/denial often follows Adcom vote, but there have been times (and recent times) the FDA has gone against the Adcom recommendation. There is a lot of pressure for the FDA to tackle the opiate crisis. I can see both options playing out, but I don’t see oral ADF label for sure.
This is all negative commentary. Will be interesting to see vote and additional comments from committee and what Elite can learn & apply.
It’s like Weekend at Bernie’s.
During this time of trade war speak and economic uncertainty, I don’t mind that ELTP does not correlate with the movement of the broader market.
Nice cherry picking. Here’s another - Elite falls 90% from highs and hasn’t come close to recovering.
Interesting thing is Remoxy received a CRL after SequestOx and yet we’re still on this meandering path.
Yes and no. Acetaminophen is considered a deterrent by the FDA for some routes of abuse (e.g., snorting).
Why do you think the stock is so low?
Here’s a hint. It is the lack of investor’s confidence in ability for management team to execute and get the job done. They have submitted multiple filings and failed each one, either through lack of expertise, misunderstanding the FDA and/or both. The picture is clear as day, but Nasrat is tied at the hip to Elite so the anchor isn’t going away.
Don’t get me started on the CFO...
Or perhaps investors didn’t really care as Elite already had an ANDA for this so it wasn’t new. Also, total market is laughable at 4.5M with 3 other generic competitors.
Please read up on this one, thanks. Lol
Those are great filings Nasdaq, but until FDA approval, the filings really don't mean squat. We could have to through multiple hoops over multiple years while watching the landscape change drastically for these drugs. They are already crowded with some big players (for those drugs of which we know). Undisclosed drugs in big markets tell us absolutely nothing that can be included in an externally derived valuation.
Lol Phendimetrazine. Lol
Have you looked at their public filings? SequestOx, Perc & Norco all got CRLs. Time to read up. Those are the 3 the FDA has responded on already. We await others. This is old news.
Look at their history. This is fact. What has Elite submitted and what has the FDA replied with? 3 for 3 on CRLs. This is public knowledge.
Interesting opportunity for sure. Wonder if a potential buyout will have to wait until after Winter 2019 results of the PD study.
Yes, that is the norm for the industry except CRLs aren’t occasional for Elite. Elite is batting 1000% here.