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But but but we have done everything the FDA has asked. This shows the same attention to detail put into PRs (or lack thereof) is the same for FDA documentation.
The truth comes out, which is completely different from what the CEO has previously communicated. But why should the investment community believe the FDA? Because "no one can stop little Elite"...except with the truth.
Yes exactly, tell that to the CFO.
Approvals are happening. How many ADFs have already been approved? How many does Elite have? That's what I thought. Zero.
That is basic accounting that you book the rev over the agreement. Quite trying to make it more complex than it is. Nice try though. Trying to put lipstick on a pig.
Still there. Here is some wording from the letter. Funny how we never hear about the harshness of the wording from the FDA. Love the QC expertise here.
Here's a link for all those that can't do any research themselves:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521289.htm
During the inspection, we determined that you submitted approximately half of your 15-day Alert Reports late (b)(4). Additionally, for abbreviated new drug applications (ANDAs) 076723 and 202248, you incorrectly submitted PADERs late, without a descriptive section, on the wrong reporting schedules
Your firm's written response is inadequate because you failed to assess the root causes and impact of the observations. You also failed to describe how you will monitor and review your actions to ensure effectiveness and prevent recurrence
In addition, we are concerned about your firm's fundamental understanding and implementation of PADE regulations, including how they relate to your use of contractors. As the application holder of 11 ANDAs, you are ultimately responsible for ensuring compliance with the Act and PADE regulations. The lack of adequate written procedures observed during the inspection and examples of failure to report safety information to FDA in a complete, accurate, and timely manner raises concerns about your firm's ability to assess the safety of your drug products.
Might want to read the PRs then. Can't win a game with all fumbles.
Haha! I am a Pisces. Says to short ELTP today through Interactive Brokers.
You are dead wrong. CFO tried booking all rev from contract as rev and at time of agreement, not earned over course of contract. You are correct that this is Accounting 101 and the CFO screwed this up royally. An intern could have booked it right. Lol
No one trusts management. Plain and simple. Otherwise there would be interest (aka volume). Just continued selling.
That is pure garbage and couldn't be further from the truth. Pricing assumptions are forecasted within in a range. If you couldn't forecast you wouldn't invest, plain and simple. It would become a hope and a wish.
CFO can't account for basic contractual revenues. No need to dive deeper there.
CEO has deflected to "marketing". Terrible strategy. A clueless plan to wing it on every level actually.
No. The forecast is what dictates the topline and bottom line and investment return. To not know this is ignoring basic financial principles. Doesn't surprise me with CFO the company has.
The entire market is not up for grabs for each of these drugs. Not even close.
He hasn't ballparked anything. Completely ignored sales insights multiple times. He hopes they return more then the investment, but he has divulged nothing.
The company has never divulged any sort of basic true market for their products. This naivety has been shown time and time again that the CEO leaves up to the "marketing guys". To not know a potential return or market prior to making an investment (or multiple ones) is ludicrous.
Overall market value is not what Elite conveys. Are they the only player on all of these markets? Far from it, but that's not what management wants you to believe.
Remember, just because kids can sell lemonade at a stand does not mean they compete in the multi-billion beverage market. That is where Elite stands right now yet with unsweetened lemonade until they can actually get an approval.
I think the FDA shot a hole through the "no one will stop us" campaign obliterating the trust shareholders had in management and the tech.
Stock sales from investors and the company raising funds is not manipulation.
Was pertaining to his objection to the 0.02 PPS. This stock has fallen so far and basically says the company has added no value since Nasrat came on board. Of course he is going to object and say the stock isn't going there. It has fallen to the point of oblivion.
The price is going to stay this low until we earn our way to a better exchange.
But the reality is we are not far from 0.02. That is something he can stomp all over to his heart's desire, but is the reality of the situation. He hates the OTC as much as shareholders, but until this becomes a reality, we'll stay close to these levels. Let's see what the next quarter brings.
The lack of Adcom proves it.
IR is not prescribed to those that have zero pain.
Because it can be deadly if the effects are not felt to appropriately manage pain allowing incremental IR tablets to be taken. Not worth the risk until the tech is fixed.
CEO has never been cautious. From throwing out extremely high valuations to the slam dunk SequestOx approval knowing internally of Tmax complications to overpromising timing and count of ANDAs. How about 3 backup SequestOx options that FDA already approved? Caution is nonexistent with the management team. Rather I think CEO makes statement without planning for Plan B or C. No buffer for timing or error along the way. Then he wings it from there.
Even if it was a labeling issue, why would a doctor even want to prescribe this to their patient when the Tmax absolutely sucks? No doctor would do that. This was actually good for the company to fix the tech.
How can you say the company is profitable? It isn't. One cannot say the company is profitable if it stops R&D since that is ongoing business strategy and for the benefit of future operations. It is what the company MUST do to have a chance at survival. To look at the company without R&D is absolutely pointless.
Per Nasrat, the FDA has already said it isn't a labeling issue. Nothing has changed. Elite didn't get an Adcom and they would have if it was only labeling. Not the case here.
If that were true it the term Immediate Release would become an oxymoron. For the sake of the patient the product needs to work in a timely fashion, regardless of diet.
Ummm...it has been 4 years under this CEO. Shares outstanding have ballooned.
Many here promised SequestOx was a slam dunk and that it would never go below 0.30, then never below 0.20 and certainly not below 0.10. We hit a nickel a couple weeks ago. How much lower do you really want?!
It comes down to a lack of trust in the leadership. Lots of talk, no action. I should say the only action comes in the form of CRLs, consistently. The CEO continues to shout from the rooftops that Elite is the tech others want. Lots of ra ra and no fruits from laboring. This is a prove it to me stock. If the warning letter does get lifted, it may be a good selling opportunity on a nice bump. But the price will fall again until an ANDA approval. Even then it will still fall again until an actual sales plan is not only launched but real sales are coming in. Show me more than hope and wishes are what investors want. Until then, nothing but rainbows and puppy dogs wrapped in a big CRL bow.
Bummer. I was hoping the Senate of the Galactic Republic. Maybe next round.
FDA already said it isn't a labeling issue. Why would that have changed?
Nothing was said about SequestOx submission or approval next year. Conversations will be had with the FDA next year, but not approval.
I agree it was a good call and they clarified a few points that they should have long ago. Still skeptical in some regards, but it was an unexpected QB sneak for some first down confidence. 80 yards still to go.
That was b4 another 10-Q debacle. Same story. Nothing new.
Watching management is bad optics.
4 days within filing of the report is still November, not October.
I thought there was a 3 day window for a reportable event. All other CRLs have been reported separately, although hidden at times in a PR, but not hidden in a Q.
Funny thing is that CRLs are now an Elite common business practice. Not even considered a separate reporting event apparently. I find this lack of continued transparency absolutely shocking and deplorable.