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Posted a few minutes ago on the Yahoo board
https://neurodevelopmental-drug-development.com/speaker/chrisopher-u-missling/
Very quiet long here. Been here Since well before the up list and RS. Just funded 2 Roths for 2020 last week with AVXL and looking forward to the near future!
I saw that myself a couple weeks back too and got excited but I don’t think it’s accurate. Nasdaq still has institutions at 23.7%
https://www.nasdaq.com/market-activity/stocks/avxl/institutional-holdings?page=5
I do smell a little desperation in the air... Todays news can only be looked at as positive. Why would Dr. Algazi a leading expert in melanoma and oncology step up his involvement with ONCS if early signs weren’t positive. No one is more familiar with current developments.
If only a PHRMA with deep pockets that specializes in CNS disorders would take a look at us in their lab??? I don't know what's going to happen, but if what we have is even 50 % as effective as some smarter people than us think, looks like we'll be alright.
Just like we've read all morning. Just a computer glitch folks. Nothing to see here, move along.... LOL
No noticeable price appreciation upon FDA approval? I have to disagree with you on that. We Will be anywhere in between .50 to $1.00 on the day of approval IMO
Yes, we can!
The odds the FDA just passes the PDUFA date under a priority review? I would say while anything is possible, here is an quote straight from the FDA
Not sure if this has been discussed. Just noticed on the FDA calendar EGLT is scheduled for an Adcom meeting for their abuse deterrent morphine on August 4th. Even more interesting is that their PDUFA date is October 14th 3 MONTHS after ours. Sure doesn't make sense that we would be scheduled after them with a an Adcom meeting with priority review and 3 month earlier PDUFA date.
Pushing timelines to the right??? OK... One flaw in your theory though. Who do you think stands to lose the most with further dilution? How many shares does Nasrat own? Same reason my bet is we will never see a reverse split. The man in charge has a ton of skin in the game, and I'm not convinced his goal is to run this company into the ground. Approval coming IMO
With all that is in the news these days, there is no way the FDA would not approve without further questions being asked publicly. Not a chance.
http://www.thepharmaletter.com/article/rationale-for-acquisition-of-epic-pharma-by-puracap
I'm sure this article has been posted on here before, but there could be lots of reasons for the silence. Approval, buyout, partnership, merger, restructuring. Who knows. One thing seems pretty certain though. No way they have bad news from the FDA to report to us. No way the FDA could possibly deliver a disapproval. Not without at least going through an advisory committee meeting first. Last I checked, Elite is not on the schedule either.
I think I hear crickets
Volume is ramping up for good reason. This has the potential to be well sustained rally. If you're going to trade/flip have a blast and GLTY... Just don't sell to early, you may regret it IMO
What future series of drug controlled substances is Epic working on?
Yes that is true. Here is from the PR. "The acquisition of Epic will provide a robust generic product portfolio which includes tablets, 2-piece capsules and powder dosage form products as well as a future product portfolio that will include a series of controlled drug substances."
Medical dictionary defines controlled drug substance as " Any drug or therapeutic agent–commonly understood to include narcotics, with a potential for abuse or addiction, which is held under strict governmental control, as delineated by the Comprehensive Drug Abuse Prevention & Control Act passed in 1970."
Very interesting, didn't realize Epic had a future series of controlled drug substances.
Wow! So ELTP has issued 3 times the total shares traded in the last 3 months!
Comprehension is key alright. LOL
This Puracap Pharmaceutical outfit, part of the team that bought out Elites partner Epic is based out of New Jersey. Hey, isn't that where Elite is from? Wonder if these two companies have ever had any reason for conversation?
From a position of strength. With approval of Eli-200 and NDA submittal of Eli-201 a R/S would be welcome IMO. Would be surprised though if it happened. Buyout before that. JMO
Wow. This release should start like this:
Dear ELTP,
Please hurry up with more NDA submittals for your ADT opioids. We are desperate.
Please enlighten us and give us the real reason
I do not mean to imply that I'm an expert. Far from it. I would suggest to Wikipedia Fda nda submission timeline and you will find answers to some of your questions.
Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter
Tell your large investing group to take a look at the FDA website. Lots of information to be found.
(Once the application is submitted, the FDA has 60 days to conduct a preliminary review, which assesses whether the NDA is "sufficiently complete to permit a substantive review." If the FDA finds the NDA insufficiently complete (reasons can vary from a simple administrative mistake in the application to a requirement to re-conduct testing), then the FDA rejects the application by sending the applicant a Refuse to File letter, which explains where the application failed to meet requirements.[6]
Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter.[7] A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months)
January 14th + 60 days is March 14th, Monday! If accepted 74 day letter by March 28th! Definitely, most exciting time to be an Elite shareholder. I am buying more tomorrow.....
I get that, but why bother with a PR for waiver of filing fee, but nothing for actual date of filing. All that did was give the shorts more ammo for no filing in 2015 as previously predicted. Maybe I'm ignorant but seems crazy to me. Thanks anyway
Lasers
Can you give any explanation as to why the company would not PR this event? Why would they not want to advertise this filing???? Makes zero sense to me....
Webster says immediately means "without delay". I think Nas chose his words very carefully. Time will tell, like it did with phase III results.
Pretty sure everything stops at 1:00 ET today.
I have a feeling somebody or something bigger than all of us put together is taking a liking here. IMHO Very quiet, loyal long here.... AVXL
I get the feeling the ones who are loading here are way less likely to take profits at low .40s. Some who bought at .20 on the last surge were out at .40 for 100% in a couple weeks. Higher lows.
I would say are chances are fantastic. Just a little more patience needed.
http://www.fdareview.org/approval_process.shtml
AVXL currently #1 on the most read board, #3 in most posted board for I-hub. Whether you're a believer or not, clearly many eyes on this story. I am a believer. AVXL long here.
With Eli-200 approval and revenue it would most certainly eclipse .30 w/o RS. Once this whole pipeline begins to become a reality and actual revenue begins to come in, the pps will move up quickly
.0002317% of the outstanding shares have changed hands today... Is this due to zero interest or something massive in the works????
That's correct sir..... Join with me!
Nothing has changed except:
We are closer to completing Phase III trial.
We are closer to NDA submission.
We are closer to the prize than ever before.
I am with the many here adding more in these last few days.
GLTA
Picked up 5k shares yesterday at .203 to bring my count to an even 50k. Went right through, no problems. GLTY
Money is right. I remember NH spoke directly about that at Rodman and Renshaw last year. Still gives us 7 or 8 years after ART launch. Buyout way before that also..