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Laughable nonsense. If you remember, past links were posted last year where dozens of pharma companies received CRL's and no doubt many of these met with the FDA to resolve their issues. Minutes were produced from all of these meetings and yet none of those were posted. These were all good and truthful companies? No. . .I don't think so. As a shareholder, I am of the opinion Nasrat is doing everything he can to obtain SequestOx approval.
the good companies do not have to because they have been truthful in the past
Did other companies have to rebuild shareholder trust by posting the minutes? Oh, that's right. . .we don't know because no other company has released that information. For me. . .there are no shareholder trust issues. Today's PR outlined the path forward to seeking approval for SequestOx and Nasrat will proceed with the plan.
maybe to rebuild shareholder trust?????
I am still waiting for proof that other companies have posted minutes of their meetings with the FDA. Just more fodder for the trash without proof (link).
Shareholders are smart.. the last thing they want Elite doing is releasing the FDA minutes sending the share price nose diving sub .05
Not fooling anyone!!
Again, I ask why should ELTP disclose the minutes when no other company has done so?
Laughable nonsense. Why would ELTP be compelled to post the minutes of an FDA meeting when no other company has done this. Post a link showing me actual minutes of an FDA meeting. If no link can be provided then the comment below needs to be thrown in the trash where it belongs.
When will Elite release the FDA minutes so shareholders can see for themselves the extent of the bad news??
Answer: NEVER!!
Today is January 20. . .the PR indicated the FDA would provide minutes of the meeting BY the end of January and ELTP would provide an update at that time.
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82830&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0
I completely disagree if you are talking about ELTP. I can provide proof/link if necessary.
Take it to the bank! I haven't been wrong yet
Yes, I know they can be shorted. I was being facetious because of the information I was given here by OTC "experts" that they could not be.
I look forward to shorting this in the new year
Nasrat, as usual, is following through with his word...his plan, to launch SequestOx.
July 18/2016
"We’re going to communicate with them, we’re going to have a meeting with them, we’re going to reach a meeting of the minds, get exactly what they want and then execute."
http://ir.elitepharma.com/profiles/investor/secDL.asp?c=1053369&ID=000114420416113849/0001144204-16-113849#LoadingArea
Now that Nasrat has met and received guidance from the FDA on December 21, he can now proceed as stated.
"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™, said Nasrat Hakim, President and CEO of Elite. Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82830&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0
No doubt very exciting news. Now we all wait until the end of January to hear what studies need to be done along with the duration.
There is no evidence that FDA changed their minds.
Is that the same nasrat that said even the fda could not stop elite??
Unfounded nonsense
there is no evidence that the FDA told them one thing earlier and another later
It wasnt a threat nasrat was delivering, it was acquiescence of not having an approveable product and having to submit to a lesser standard in another country to hopefully slip it through
Keep it real
TROUBLE with FDA/Sequest... Everything else is irrelevant !!
Absolute BS is correct. So I was told to look for that huge sell off that was supposed to happen today but it didn't happen. So much for accurate information. LMAO
Look for HUGE SELLOFF Monday!!
I was told today (Monday) would be a huge sell-off for ELTP. So much for the great information!!!
Does it count if the information provided is ABSOLUTELY WRONG?
Thanks for that great information!!
Thank you Couch and Nasdaq for the kind words.
Hey I only deal in facts. Sorry
Here we go again:
-yes FDA meetings finally did occur, but not when Naz said they would - Nasrat has stated a number of times the proposed FDA meetings are determined when they occur by the FDA and ELTP. ELTP goes by the FDA timeline and not reverse.
- LOL one of the great myths about elite is that FDA changed their mind about P3, that is total BS, were promised NDA by end 2014 [color=red]- Absolute BS. Nasrat stated on November 19/2014: "The FDA keeps coming back that they may want to see an efficacy [trial] and that’s what we’re negotiating with them. If they do and as I’ve said I have anticipated that they may ask for it, [indiscernible] there are certain things I may or may not ask for." Waiting for the FDA decision delayed the NDA submission by eventually prompting a PIII efficacy trial.
[/color]
- yes he did miss the 2015 filing, thanks for noting this - LMAO by two weeks and that was (as previously stated by Couch) to apply/process an NDA application fee waiver for 2.3 million dollars.
- Safety issue- yes we are still waiting - and I am still waiting for you to prove where/where Nasrat said "any day now"?
I really need to add some additional information to your list:
FDA meeting(s) - yes they did occur in 2014 and 2015
NDA by end 2014 - September/2014 NDA was on track to be filed by year end. November/2014 the FDA advised a PIII may now required. We will let you know in due course. An FDA decision was finally rendered early 2015 prompting an PIII efficacy trial.
No P3 needed - absolute BS. November/2014, Nasrat was advised by the FDA a PIII trial may be required- see comments above.
NDA by end 2015 (notice a recurring theme?)- ELI-200 NDA was filed on January 14/2016. Wow, Nasrat missed the year end filing by two whole weeks.
resolution of Safety issue any day now - "any day now" - when did he say this?
LOL LOL
Didnt Nasrat say organically grow into nasdaq in 2016 with no RS and that evolved into nasdaq in 2-3 years with aid from RS??
Again, complete nonsense.
Didnt nasrat also buy shares at 31 cents? So much for confidence.
Complete nonsense
Historically, this has been a very, very bad omen for penny stocks
Speaking of the CRL wasn't Nasrat supposed to meet with the FDA this month and let us know when SequestOX was going to be approved or new test's run? What's up he said by the end of August he has what 2 days left?
He said it in the CC on JULY 18th Monday after the approval failure. Another LIE by the CEO!
Absolute nonsense. I do not recall Nasrat saying he would be definitely meeting with the FDA in August. Try reading this:
"On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different ole, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, we are at DE, but first we need FDA’s feedback and blessing.
We met Camargo and other consultants and are in process of preparing a package for the FDA shortly requesting a type A meeting. The process is a little complicated and it takes time. You first have to send a letter to the FDA requesting a meeting, once they grant a meeting and give you a date, you need to send them a package with all the testing and evidence that you need to present so they can review it before the meeting. Then we complete the work based on the FDA feedback’s and then we submit the new data and meet with them again to make sure that we delivered on the clinical trial that we said we’re to deliver on and they were successful. That’s when the whole thing gets concluded, at least this is the path forward.
I should have more details for you by the next conference call."
http://seekingalpha.com/article/3999933-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2017-results-earnings-call-transcript?part=single
Transcript for: Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q1 2017 Results Earnings Conference Call August 11, 2016 11:00 AM ET
http://seekingalpha.com/article/3999933-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2017-results-earnings-call-transcript?part=single
In your "expert" opinion will we get pounded in after hours trading today? LMAO
No, sorry it was not me that claimed that nonsense as fact. go for it though
If we are going by the list of questions gathered/posted by Mocha Jet on previous occasions, it would be possible to verify whether these questions
were answered by cross referencing with the appropriate CC transcript. If you want to prove something. . .go for it.
the proof is that my questions were not addressed by nasrat and co, Gee I wonder why.
sorry, yes you are entitled to your own opinions, but the FACT is that we do not know what questions were avoided. But thanks anyway
Wow. . .talk about lots of conspiratorial comments about the upcoming CC tomorrow. The fact is there are thousands of OTC stocks out there and only a few conduct CC's because they are not required by the SEC and yet Elite Pharma has followed through with these events even before Nasrat had come on board. All of the CC's I am familiar with have always had a Q/A session at the end of the call.
The following transcript links shows there has always been Q/A session towards the end of CC:
http://seekingalpha.com/article/1203841-elite-pharmaceuticals-ceo-discusses-f3q13-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/1518902-elite-pharmaceuticals-ceo-discusses-f4q-2013-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/2295735-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q4-2014-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/2433325-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q1-2015-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/2696615-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q2-2015-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/2927936-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q3-2015-earnings-call-transcript?part=single
http://seekingalpha.com/article/3263515-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q4-2015-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/3429196-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q1-2016-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/3885716-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2016-results-earnings-call-transcript?part=single
http://seekingalpha.com/article/3983163-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q4-2016-results-earnings-call-transcript?part=single
The CRL is kept confidential. As such, there will likely be NO DISCLOSURE of this document ever!!
I see what you mean. Touche? Yes, both technologies use naltrexone (antagonist) to negate the euhoric effects of the opioid if the medication is tampered with. I can see why Nasrat would say the two are the same. Where the technologies differ (in appearance) is that Pfizer's version (if I remember this correctly) consists of a single bead, hard turtle shell where the opioid and naltrexone is sequestered whereas Elite's version consists of a capsule containing micro-beads with the opioid and antagonist mixed together.
Tell that to Nasrat. He is the one that is claiming the technologies are very similar using his own words. Guess mgmt needs a chemistry 101 refresher according to you.
It was posted by a Hakim spelled backward poster and then they removed it and admitted it was fake news.
With all of the eyes on ELTP and if SequestOx had been approved, would it be fair to say the share price would have appreciated with this approval? Call it a wet dream or whatever, but it is my opinion we will be provided information next week as to what has to be done to get SequestOx approved.