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Creating false expectations. Nasrat stated by the end of January. Nice try though.
You are spot on. If/when SequestOx does get approved we will get the manufacturing profit, but also an additional small % split. 2017 will be make or break for the company. Other tech is being developed fast.
I didn't say Elite was a junk stock. I am pushing for realistic expectations on timing of next steps. The ball is in Elite's court and will be interesting to see if management can deliver in 2017 or 2018. If they can defeat the odds, the potential returns will be monumental.
I assume you also read the disclaimer at the beginning of the deck:
This presentation reflects the views of the speaker and do not reflect official FDA, HHS, or other government opinion or policy.
To your comment, some people will see what they want to see. To the detail-oriented there is much more.
Not at all, they are those that don't ignore critical data and that can differentiate the two. Best of luck.
I could also point out data flaws that I noticed in this deck after 2 minutes of reading that lead me to be concerned over the data integrity of the presentation.
These aren't the exceptions. Welcome to the wonderful world of the FDA. Too many inexperienced traders read into posts that are entirely optimistic and create unrealistic hopes. This is reality.
Don't overlook the footnote:
**Performance goals in the chart means FDA should take an action on a certain percent of applications, etc. within the timeframes listed; it does not mean FDA should approve applications, etc. within such timeframes.
An actual approval may require a series of application adjustments and amendments dragging this out far beyond 2017.
For example in how fast the FDA moves, how many years have we been waiting for simple site transfers?
There is a path forward, but we have no idea what that means. Could be one or multiple trials.
I like the CEO. He hasn't been perfect, but he has done as well as anyone could despite the initial cards dealt. It is not uncommon for Sr team members at large organizations to run smaller companies, especially startups or companies in need of turnaround efforts.
Sadly, this doesn't signal anything. This is often the case with penny stock biotech/pharma. If they sell, the retail seller follows plummeting any remaining value.
You know very well how FDA minutes work. Agreement needs to take place between Elite & FDA on what was both discussed and agreed upon. Nothing new here and you know it.
Wow! Unbelievably sad regarding the lengths people will go to for profit. Absolutely disgusting. I was worried about Fentanyl craze as Elite's tech can do nothing to stop it and not sure what tech could. Hopefully shutting down the pill mills will resolve the issue.
Come on. You think the company will prepare, complete, analyze, write up, fix NDA, submit
& have it reviewed and approved by the FDA in that timeframe? Pure BS. We'll know more in a month, but depending on the study 2017 approval may not be realistic.
I would completely agree with your timing. Approval could happen in 2017 if everything falls into place and unknowns are non-events. With how long it took to get the CRL review I don't think we have are labeled as a Class 1, but just my impression. We will know more soon enough.
Merry Christmas all!
Not a soft bash. We simply have zero insight into the timeframe. Hopefully just weeks away for resubmission vs months. When you step back & understand that it took 6 months to even meet with the FDA you realize how slowly things really move. Retail investors are expecting speedboat to type moves from the titanic.
The minutes and action items must be agreed upon by both parties. Leave it up to the government to add red tape. In any normal business meeting this is done before the meeting concludes. Absolutely ridiculous if you ask me.
It was expected that this review meeting wasn't going to take 6 months to take place. Sad, but true. You need to ignore fake news mentioned here that they are on phone with FDA, meeting with the Elite the weekend after NDA rejection, etc. These are just ploys to minimize their portfolio damage.
I bought more last week under 0.14 and thought about selling on yesterday's predictable second morning spike. I share your same concern that the news was overhyped. Nasrat provided hype pre-FDA minute release. My interpretation of this is that it is to push against last minute tax loss selling pressure and/or additional dilution for needed studies. Great to hear meeting wasn't positive, but not holding my breath until we have more details about cost & duration required for resubmission. For all we know we might be 2 years away. It is a significant unknown and failure to realize this is a critical error. In the end, I held the shares until we know more in a month's time. No reason to break out the bubbly quite yet, but we may be getting close.
My interpretation of the process is that the $2.3M waiver could have been applied for post-submission. I don't recall offhand how tight cash was, but in the end it was only a 6-week or so delay.
Interesting thought.
I won't get too excited until we hear more at the end of January. My guess is the FDA ok'd or tweaked one of their proposed studies. We have no idea on duration of study at all - will it take a few weeks, several months, etc. I am curious as to what is still remaining for them to prove out. Regardless, it will be fantastic to jump this final hurdle to get this pipeline really cooking. More to come in 4 weeks.
Was pondering selling all shares a couple months back from all my portfolios. Stepped away for a while and thought the risk of holding continued to be pretty good. Added more recently at 0.1365.
I would expect next week to be rather volatile due to lower volume and last week to sell out for tax loss.
I think there must be or there would have been wording about a near-term resubmission.
You are actually spot on this one as there is technically risk due to the NJEDA bonds, but generics have that covered. Bankruptcy is out of the question.
I don't think we'll get any news anytime soon. CEO won't even allow Q&A after the NDA debacle. If we were to get bad news I am certain it would be this Friday or next week as most will be on vacation and mgmt will try to spread and minimize damage.
But didn't the CEO say the company at a minimum is worth $0.40?! Oh wait, that was before the company was diluted to smithereens.
Their NDA filing was already denied. What else is there to say?
They won't post anything until minutes are finalized, which at most could be 60 days. This meeting wouldn't require an 8K, but will be up to mgmt to disclose on their own merit.
Lol. Yep, sure they will. Just like nothing will stop Elite, not even the FDA. More like Elite will be a success with all drugs not approved by the FDA.
Great post. Book knowledge is one thing. The application of that knowledge along with disciplined trading is a completely different ballgame.
Funny thing is that I've just started teaching my wife how to daytrade. It is extremely profitable.
Quoting garbage quotes doesn't count as research.
That quote has been recycling for years. Pure garbage at its best. The only people who use that quote are failed traders
FDA approval is months away at very best if not years.
We can gauge this by Prior Elite CT Orders that it is of no significant value. History isn't a perfect guide, but it is all you have in this case other than just hope.
Only need one? Sounds much more like a wish list than a strategy. Elite's CEO pushes hope and until we hear anything further, the FDA says another.
I don't daytrade this one, but when I do actively trade other stocks my major premise is that the market ALWAYS overreacts creating swing opportunities to capture on long & short sides.
What makes you think we'd hear something so quickly? Meeting minute protocol can take up to 2 months to be finalized. Perhaps I am missing something. Last couple slides discuss meeting minute protocol:
http://www.fda.gov/downloads/Training/CDRHLearn/UCM387291.pdf
I think Elite is trading at a slight value, but not much until we know more regarding FDA/Elite conversations. I think meeting minutes can be delayed up to 60 days depending on the final version. We are all eager to better understand next steps.
Regarding Percocet, how many others are selling generic version now?
ELTP is far from the first for whom the FDA has moved goal posts. Elite's destiny rests in their hands. They call the shots, not Nasrat. Oh yeah, and the FDA can stop Elite...again.