Replies to post #410098 on Elite Pharmaceuticals Inc (ELTP)

[imanjen13]

Ok Mozy here's my opinion since you asked.
You are obviously nervous based on past experience when your were greedy and didn't take any money of the table even when stock was close to a buck. Your present total cost is $47,000. Why don't you sell 125,000 here for $49,000 and you will own 400,000 shares free and clear. You will sleep much better and if the worst happens and Vyvanse is not approved, you can buy back shares much cheaper since the stock would likely fall.
Feel better? Good luck.

[HGiLS]

The answer of your question about Vyvanse is in the August 15th 2024 transcript.

Read it again.

[jour_trader]

With an approval being a binary decision, there is always risk, despite Nasrat once claiming that the FDA can’t stop Elite. Well, yes, yes they can.

The stock price would take a hit if Vyvanse isn’t approved, but I think it would only be temporary. Is the issue fixable, what’s the timing, etc.

With just the known drugs that we know will launch over the next couple quarters, without Vyvanse, I would value Elite closer to $0.60 once they launch and start getting traction and capturing market share over the next several quarters.

[WeeZuhl]

What is the chance it’s not approved and what would the impact be to the stock price? Would we sink like what happened the day we got the CRL for SequestOx? I realize we have so many other irons in the fire but it seems that’s the one being focused on to get us to $1 and just curious. If y’all were betting, are we like 90% certain we are getting approval? 80%?

Mozy429 your concern is reasonable. This stock is trading just like it did in 2015/2016 when the SequestOx review was underway at FDA. At that time, we also saw a vertical leg up from the teens to the thirties, based solely on the anticipation of a "sure thing" approval. But shareholders had been misinformed. We were told SequestOx was bioequivalent when it definitely was not. That was just a plain old lie, no two ways to describe it. Also, Purdue's Avridi was an immediate release oxycodone ADF, similar to SequestOx, and it was killed off at an FDA AdCom meeting in September 2015 for the exact same problem with fatty meal bioequivalency. ELTP management knew at that time that SequestOx was out of range by a similar extent and was almost certainly going to receive a CRL. Nonetheless, this fatal flaw was described as a "labeling issue" to shareholders, who had already been lied to about SequestOx bioequivalence. When the inevitable CRL came through in July 2016, only shareholders were surprised. ELTP management knew or should have known it was coming for at least nine months by then.

In 2016, shareholders did not have a fair basis of information to properly assess the likelihood of SequestOx approval. We had been given incorrect information about bioequivalence and labeling issues, and we had not been given important information about the similarities to failed Avridi. What we thought was a sure thing was anything but, and our anticipatory jump up in share price became a falling knife in one day. You better believe the exact same thing will happen again if Vyvanse approval does not happen this year (or even if negative comments are made during an upcoming call). The entirety of the recent vertical SP move from teens to thirties is based solely on a few comments during a conference call, and there is a long history of bogus ELTP anticipation based on meritless comments made during safe harbor conference calls.

I'm like you Mozy429 in that I don't regret any of my ELTP buys or any of my ELTP sells, but I do regret some non-sells. Like you said, live and learn, and I know better now than to believe anything with this company is a sure thing. When you see posts expressing 100% confidence of approval, you should chuckle and move on. When you see posts talking about $7 valuations, well I would love that, but you know those same posts have been prolific on this message board for more than a decade. You know some of our most enthusiastic friends and ELTP advocates have died while waiting for their predictions to come true. When you see posts talking about going all in and posts that suggest converting 401k's, you know that any penny stock is a highly speculative investment, especially this one. When my wife and I wanted to quit our crappy jobs and start our own business, it was not my shit-ton of 3-cent ELTP stock that my bankers cared about. They cared about our home equity, 401k's, Roths, and 529's. Those are the assets that made the bankers believe we were still good financial risks even though neither of us would have a regular paycheck. If you're going to put all your eggs in one basket, then you better be ready to sit on those eggs for a long, bumpy ride.

With ELTP's generic Vyvanse application, I don't know what I don't know. Remember with SequestOx, when we heard about the "labeling issue," it seemed like Hakim was giving good news about its potential approval, but in reality, it was a fatal flaw. So now fast forward eight years- what is the "API issue" with Vyvanse? Is it a small speed bump or fatal flaw? Don't expect the full story from ELTP management.

There is no shame in taking profit. There is no shame in protecting capital. There is no shame trading for free shares. There is no shame in buying the rumor and selling the news. Good luck, Mozy429, and thanks for taking the time to express honest concerns.

ELTP share price since 2015:



An outright lie:

Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study For Abuse Deterrent Product ELI-200

Northvale, New Jersey, Wednesday, March 05, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.

[kayak_wench]

At $0.40 we have only priced in the billion dollars in market potential of the new opioids. When they come to market (which they are already approved, so they will) our P/E will drop from the 20s to the low teens thus hitting the average for generic drug company. In fact the price doesn't seem to be reflecting that possibility of Vyvanse approval at all (hence some argue it is still a time to buy) . So you do not need to sell now as some are suggesting you should consider. Granted if we don't get notice of an approval in November as expected price will drop and P/E will drop in the near-term. But as the increased profits from these opioids roll in price will recover to at least $0.40 but likely higher over first quarter of next year. Then combine that with the extremely high un-likelyhood that Vyvanse will never approved, and the suggestion to sell now sounds like particularly poor advice.

Keep in mind that someone comparing Vyvanse to SequestOx is like comparing apples to monkeys. SequestOx was not a generic already on the market and being manufactured by multiple companies. It was a novel patented product so the BE was of course more challenging. The bar for success is much much lower for Vyvanse. Maybe we get a delay because FDA can always find something if they want to, but Elite will eventually bring Vyvanse to market.