Replies to post #180941 on Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

Successful formulation/technology: COMPLETE

Pivotal BE Study: COMPLETE

Registration batches: 6- mos ACC, 24- mos CRT: COMPLETE

Lab Abuse Study: COMPLETE

Liking Study, Intranasal: COMPLETE

Fed Study: Dosing COMPLETE

Withdrawal Study: Dosing COMPLETE

Efficacy Study: Dosing COMPLETE

Pediatric Study: Post product launch

Elite's First ADF NDA Filing- ELI 200: COMPLETE

FDA NDA Acceptance: Imminent

NDA Expedited Review: Imminent

ELI-200 Launch: Scheduled for 2016

[Couch]

Given the FDA waiver of $2.3 million - why would Elite wait any further to submit. Doesn't make any sense. Not to mention Elite garners $2.5 million dollars from Epic upon filing Eli 200 - and that is the exact amount of shares Epic sold recently. There is no reason to think Elite would delay submitting Eli 200 after the waiver. That is unless you have some facts beyond "speculation".

Btw once Elite files the NDA - the FDA has 60 days to decide whether it will review the NDA or not.

Here perhaps this link might help:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

Drug Review Steps Simplified

Preclinical (animal) testing.
An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
Phase 1 studies (typically involve 20 to 80 people).
Phase 2 studies (typically involve a few dozen to about 300 people).
Phase 3 studies (typically involve several hundred to about 3,000 people).
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
FDA reviewers will approve the application or issue a complete response letter.

[Don'tDrinkTheKoolAid]

Hopefully will all find out at the next CC. Within the next month from all speculation going on.

[no2koolaid]

Perhaps the confusion is over the word - immediately. Check the link, second paragraph...

http://finance.yahoo.com/news/fda-approves-waiver-nda-filing-215222660.html

As per the 1.13.16 PR..."Elite will immediately submit..."

Once the fee waiver negotiation was complete and announced, there is no reason for a delay. Otherwise the CEO would NOT have said IMMEDIATELY.

Third paragraph, third sentence..."I look forward to hearing from the FDA concerning a notification of acceptance for review in the coming weeks." NOT MONTHS. PERIOD!