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I'm sure you are right, Samsa
Good old-fashioned silliness
No Norco
Ashok Nigalaye hasn't filed a Form 4 since he resigned as director more than 3 years ago. He could hold zero shares at this time and we would never know. Luckily, I couldn't give a rat's ass (other than I'm glad to be done with those Epic dudes).
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142755556
Footprints in the Sand (ELTP Edition)
One night I dreamed a dream.
As I was walking along the beach with Nasrat,
Across the dark sky flashed scenes from my life.
For each scene, I noticed two sets of footprints in the sand,
One belonging to me and one to Nasrat.
After the last scene of my life flashed before me,
I looked back at the footprints in the sand.
I noticed that at many times along the path of my life,
especially at the very lowest and saddest times,
there was only one set of footprints.
This really troubled me, so I asked Nasrat about it.
"Nasrat, I noticed that during the SequestOx CRL and reformulation failure,
there was only one set of footprints.
I don't understand why, when I needed you the most, you would leave me."
He whispered, "My precious shareholder,
I love you and will never leave you,
Never, ever, during our trials and testings.
When you saw only one set of footprints,
It was then that I carried you."
O SequestOx, Where Art Thou?
Let’s first recognize the fact that Nasrat doesn’t need the FDA to tell him how to run a pivotal BE study. He’s done at least half a dozen since he’s been here, and he hasn’t gotten prior instructions from FDA on any of them. He can go ahead and do the study as he normally would, and worst case would be adding a few more subjects at the end if they want a bigger study. I don’t think this is true, but it is possible that the pivotal BE is already started and either ongoing now or already finished. It doesn’t sound that way to me when Nasrat discusses it, but he is awfully good at being coy when he wants to be. He usually only PR’s a pivotal topline result, not when the study begins. When he hears from FDA and he knows he has sufficient number of subjects, then he can drop the PR that pivotal BE is complete and resubmit the application (assuming nothing else is required). Again, I doubt this scenario, but I do think if the pivotal BE is not yet substantially complete, then there is a reason, and that reason definitely is not because we’re still waiting to hear back from FDA.
My best guess is that Nasrat is pumping the brakes on SequestOx. Quietly slowing it down but not publicly saying so. Essentially he is pushing back the need for the $1+ million expenditure until revenue and/or share price increases. “Just taking a little breather” is what I think, and the FDA makes for an easy target to blame for the delay. I also consider the possibility it is a hard brake on SequestOx. It could be an indication of the transition away from naltrexone ADF’s and towards the new, less expensive, patent-pending ADF tech. He already shelved the naltrexone versions of Percocet and Norco, and ELI-216 is seemingly permanently blocked by Troxyca’s failure to launch. One must ask: is this the end of the 2 bead antagonist ADF? I doubt it, but it might be. Another point to consider: of the ten drugs FDA-approved with an ADF label, five have never hit the market: Troxyca, Ventrela, Morphabond, Roxybond, and Targiniq. There is a problem in the ADF opioid market, especially for extended-release opioids not called OxyContin. As we see Elite filing ANDA’s for non-ADF opioids, CNS stimulants, antibiotics, beta blockers, etc., it is clear that ADF’s will be a less significant part of Elite’s future than previously thought.
So after all that, I admit I don’t know what the hell is going on with SequestOx, but I do know for sure there is more to it than just waiting for the FDA to tell us how to run a pivotal BE study.
Keep up.
Was this meant to be funny? It is.
REPOST 12/2/17: Historical Milestones
For those who have been around for awhile (hi doc!), you may have already noted that we're approaching the ten year anniversary of Elite as a penny stock. The early years from 2000-2003 were tumultuous, mostly in a downward direction. Think Red Dragon where Dollarhyde lit the tabloid journalist on fire and sent him careening down the hill in a flaming wheelchair. Started at $14 with plans for 24 hour oxy and antagonist ADF. It hit the buck fifty range in a little over three years, by March 2003. That whole time period has been sent down the rabbit-hole and expunged from official history. No PR's exist in the elitepharma.com online archive dated prior to March 2003, and the first one is from the board saying the founder and CEO Mehta couldn't have quit because they had already fired him. The two sides settled for cash in exchange for the patents. When Mehta later sold out all his shares, it was around 1.3 million total, which is funny because I have a bunch more shares than the founder ever had. I'll have to check, but I think the authorized share count might have been a tad bit lower back then. Check out that earliest PR and you'll see somebody you recognize (hi Dianne!).
After Mehta came Buddy Berk. The share price remained volatile but overall bounced up and down off of a $2.00 base for years. Ten years ago this week on 11/29/07 it closed below 2 for the first time. Then it got ugly. For Elite in 2008, think Die Hard where Mclane throws Hans Gruber off the Nakatomi Plaza. January 2 was the last time it ever closed above $2, and just like that one month later it closed below $1 for the first time. March 26, 2008 was the last time it closed above one dollar, and as of that date in 2018, Elite will have been a been a penny stock for a full ten years. Buddy Berk got as far as getting a SPA from FDA for a Phase 3 study for ELI-216, what would have been the first ever oxycodone antagonist ADF, but by then the company was in no shape to do anything with it. September 19, 2008 it closed in single digits (.07), and by November 2008 Jerry Treppel was brought on to the board and Berk was out.
Acting CEO Chris Dick and Treppel et al saved the company from bankruptcy with the Epic Strategic Alliance in March 2009. For this, think of the beginning of Braveheart where Longshanks rides with a heavily armed unit of cavalry into the middle of a wedding party and eats all the food and takes away the virgin bride to invoke his nobleman's right of Prima Nocta. For less than $4 million, Epic's three members ended up with three seats on the board and enough Preferred shares and warrants to ultimately, effectively control the company.
Barely breathing, Elite was delisted from Amex in May 2009. Treppel was named CEO in November 2009, and he became like Travis Bickle in Taxi Driver, ensuring the survival of the tough but vulnerable young prostitute Iris, who every day does whatever is necessary to survive, no matter how low. Treppel moved the company toward generics, starting with methadone in 2009. The next year, Elite purchased the naltrexone ANDA from a company called Mikah Pharma. I'm sure with a funny-sounding name like that, we'll probably never hear anything more about them.
It's a miracle this company didn't go bankrupt in 2008 or 2009. But it didn't. It's like in Stranger Things, when Eleven uses her power to stop Mike in midair as he free-falls off the cliff and toward the bottom of the quarry. An Epic survival, literally, mainly on the back of Lodrane-24D, an illegal decongestant with enough stimulant to suck every secretion dry until your mucus membranes are fully-desiccated and you can't pee or poop right for a week.
I bought my first shares on May 10, 2011, 10,000 shares at 14 cents. Soon thereafter the FDA pulled Lodrane-24D, and I got my first taste of life as part owner of Elite Pharmaceuticals. Treppel transitioned the company from survival to growth, and handed the baton to Nasrat Hakim. It's hard to imagine everything that has happened since then. How far we've come but how little we have to show for it. But the antagonist ADF tech the company was originally based on was way before its time. Even now, with the opioid epidemic in full bloom, we still allow kids to snort non-ADF IR opioids like oxyIR, Norco, and Percocet. It never had a chance in the early 2000's, which was years before anybody ever heard of OxyContin, Hillbilly heroin, or pill mills. If ever there was a time to commercialize the original ADF tech, now is it. Elite has ready-to-go antagonist ADF versions of Norco and Percocet, and as always, the ADF oxyIR version should be ready to go soon. Maybe someday somebody will decide we ought not to let kids snort this crap. After all these years, Elite is ready for that day to be today.
Elite's filed and pending ANDA's
1. Methadone
2. Norco
3. OxyContin
4. Adderall
5. Concerta
Oh my. Percocet approved and launch is imminent. Three-year isradipine Phase 3 study finishing up this fall. SequestOx moving forward. New ADF tech development. Good time to own shares.
False.
Hey Kids! Wanna be bigger than The Beatles?