Elite Body Slammed By FDA!

And let the blood bath begin.  Elite's management's silence was proven prophetic.  The FDA, for as of yet unspecified reasons, denied Elite their entry for their massive hitter, SeaQuestOx in post-trading hours on Friday.  And just like that a 10% drop (pre announcement) and more slide appears to be on the horizon.  It happened just as the "haters" described, and the lesson to guys like Couch, and others who attacked varying opinions of ELTP's technology, that a level, objective approach is really the only approach.  Pumps and Rah-Rah's INFLAME the folks who have been here before, or just have good knowledge of how these procedures evolve.  The pumps were easily the problem in the boards and this decision proved that.  Were any of them able to post facts, ask questions and refrain from EVER using words that could be interpreted as anything but objective, then and only then will the discussion sell itself, or improve if not good enough. 
This problem that Elite faces may have a lingering damaging affect on the share price, with some longs still hopeful that this could be a "details fix."  Others are not so sure.  Here's some of the comments from today, but first the news:

Elite Pharma receives Complete Response Letter from the FDA regarding the New Drug Application for SequestOx for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate (ELTP) : "We are evaluating the CRL received and hope to meet as soon as possible with the FDA to discuss how to address their concerns. We will work closely with the FDA to determine the appropriate next steps and path forward for the NDA"


Comments....

RLSJ84	Friday, 07/15/16 10:43:11 PM
Re: no2koolaid post# 213769
Post # of 213785

Transfer of site manufacture was still pending as of last CC. There had to be approval for the site transfer in order to move generics to and I believe in order to produce sequestox.

Labeling. Nasrat was very very adamant about ADF labeling that maybe he wanted best label possible and they didn't want to give it.

Maybe the FDA needed more time. 4 people short for ADCOM, pressure from outside to solve the opioid crisis made them now over protective of giving approvals, or anything else the FDA does. It's goverment.

I do not believe it was the technology. It wasn't the drugs itself. Oxycodone already approved and naltrexone already approved. Nothing new there. Agonist antagonist technology already know how it's supposed to work.

I can not see reasons so major that would require months to years to remedy. Extra studies as if the FDA now says it wasn't good enough. They accepted priority review for a reason. There was sufficient evidence provided that this new technology is better than what's available. They had time to schedule an ADCOM which they didn't.

So one can draw to the conclusion based upon facts and guidelines that chances are it is minor in nature. But we won't know until Nasrat goes to the fda to discuss pathway to approval.

He won't tell us nor should he. No he could do what Kempharma did. After their CRL which was their fault trying to ammend 3 days prior to PDUFA date, started putting out PR on regards to their other pipeline drugs to soften the blow. A sort of look at my right hand to draw attention away from my left hand ,CRL, by taking attention off it.

But it's still there. Not rejected. Approval I think will still happen

RLSJ84	Friday, 07/15/16 10:51:50 PM
Re: no2koolaid post# 213776
Post # of 213792

I could still see approval happening (barring any MAJOR work or studies or data being needed) before end of year.

I will be here. I'm not willing to walk away from another company to only miss out on the approval because I was impatient. I've got bigger stakes in this that if approval does come it's too much to shrug off as a loss.

This is not your typical OTC company. Revenues and actual patents, generic approvals, technology that is actually cutting edge toward an epidemic, and a CEO who has too much to lose and isn't selling his shares. Not your typical OTC company.

A.  dr_lowenstein	Friday, 07/15/16 09:22:58 PM
Re: John_Langston post# 213727
Post # of 213806

Hi John, I have been busy all day did something bad happen to eltp today???? Did the approval come through with the label as promised?

B.  John_Langston	Friday, 07/15/16 09:48:04 PM
Re: dr_lowenstein post# 213732
Post # of 213806

I’m not sure; a prospectus was filed pursuant to rule 424(b)(3) (424b3) about some complete response letter and now everyone is all up in the air. You know I’m just a dumb OTC stock trader and I have no clue what all that means.