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Hilarious. Just read your post. I think it would be waste of money.
Not sure why the thought of biting the hand that feeds is even being entertained. With so many potential submissions in the pipeline why would you even dare stir the pot with a legal pursuit.
Still sticking with July 14th? Just curious if you are moving the year out 2 or 3 years.
And yet that same agency has the final say. What garbage did I see posted here so many times? Oh yeah "nothing will stop SequestOx from being approved. Not even the FDA. " That was foreseen to be 100% accurate. Definitely nailed that July 14 date as well.
Not the first time the FDA has change their mind. Won't be the last either. If SequestOx is resubmitted, the FDA will probably change their mind again.
Yes, such great experience and yet they couldn't pull it off for the initial submission. Still shooting for July 14th to capture 90% of opiate market?
I think some people are still looking forward to July 14 and how the FDA will not stop them, the product is perfect, and will take over the entire 90% IR space.
Nothing can be assured at this point.
But that is old news. Can't live in the past. FDA has stated it is a safety issue, which is the primary reason why the CRL was given.
Your labeling adjustment assumes Tmax falls within an acceptable range. I don't think that's the case here or we would have received an adcom to discuss labeling.
No, it is tapped out meaning no more shares to register. Zero, zilch. Not sure how else to simplify for you.
I don't think this is Lincoln selling. I think it is longs unloading & stops being hit.
Why do you think the S1 was filed? It was to register the remaining shares for Lincoln. There are no more after this.
Except FDA clearly said labeling alone can't fix it.
I am very well aware of that. CEO wasn't planning on CRL. More funding will be needed for trials. Cash needs to come from somewhere as LPC v2.0 is now tapped out.
Plus Epic Oxy profit share.
I agree with your commentary. On a side note, with Aug submission of an ER, that has higher likelihood of approval prior to SequestOx. There is potential upside there, but not counting on it yet. Too many unknowns at this point. We may also see a reverse split, but not for the reasons we had hoped just a mere few months ago.
Approval is one thing, but revenue generation and prove of market penetration is another. Not sure another filing is going to do too much at this point after just getting a (hopefully) temporary rejection. I mentioned months ago that Elite became a show me stock & has to prove both concept & revenue. I received several ROFLMAOs as well.
I see where you are coming from, but the very foundation of the company just got decimated. The core & lead pipeline product got rejected - without a plan in place yet causing uncertainty. The entire company relied on SequestOx approval which made Elite a house of cards until we hear more. Market hates uncertainty & we have a ton of it right now. SequestOx approval was the ticket to stopping further dilution.
Those that want to exit know they can't all at once and are spreading it out while demolishing the PPS.
It is also because they cannot sell. After quarter closed before public release - no shares can be sold by public companies.
So why do you deviate from what the CEO has stated publicly? Just curious.
Goal post moving is in the past. Need to get game on for going forward. Will just take a little longer than expected & at more cost.
CEO still needs to be sold on that one. He knows much more than the public. Not sure why he capped at 400M for total sales. Wonder what major impediments they see to selling more than that.
Heard same regarding July 14th.
I just threw a figure out as we have no idea how far beyond the acceptable Tmax SequestOx goes. It is anyone's guess at this point. We simply don't know. All we know is that the Tmax was way out of whack from their acceptable range to the point labeling couldn't minimize the risk.
FDA isn't looking for just another reg oxy. They are looking for a deterrant that minimizes risk across the board, not introduce new risks. The fact that Tmax lag is beyond reg oxy is a real concern. Patient seeks relief immediately, not 4 hours later.
Great questions that we all are asking ourselves with no definitive answer. These will remain as questions until the company provides more insight.
FDA specifically said labeling won't mitigate risk. I think they will have to prove better Tmax with another BE study.
Yes. This is the black out period for all public companies as insiders have insight as to how the quarter went. One way around it is to have an ongoing share purchase plan that purchases X shares every month or quarter so as to not trade on inside info, but highly doubt any have that in place.
I guess it was really meant all along July 14, 2018? Correct?
I find the labeling insights interesting, but the question ai continually ask is why a CRL? Why didn't the FDA allow discussions to begotiate labeling? There is more here than meets the eye to what investors are privvy to, especially since we don't have Tmax data until we get an adcom. Until then we are guessing as to how far out of bounds the FDA has gone, if at all.
CEO doesn't have 100% confidence in ERs. As he stated in last Monday's call about Tmax issue:
"The ER’s will not get a similar response MOST LIKELY." That really doesn't sound like 100% confidence to me, but last time some here were confident about July 14th. We now know how that went when the CEO's words are twisted.
Exactly right on no trading of securities after period end before public announcement. Didn't even consider that timing.
Reread the post you responded too. There was no mention that investors are owed rights to all the data. The opposite was acknowledged & understood.
The term bioequivalent was used. It is only partially bioequivalent. This was not disclosed until Monday. Surprise shareholders!
I thought about that last week as well, but was hoping to see some this week. That would be huge vote of confidence.
Where does the buck stop - with the CEO who calls the shots. If Tmax data has been hidden all this time, how do we know that there aren't any other bombs that will be dropped. Trust has been cracked,
not shattered, but getting close. Will be interesting to see how CEO presents in few weeks at next cc.
That's what I thought. Lol
No, the issue is the CRL and the route the company has taken to keep pushing forward despite a faulty product - only now divulging it. Labeling complexity adds challenges to sell. Getting the product approved is one thing. Selling it to doctors with the labeling complexities is a whole new challenge.