Replies to post #202255 on Elite Pharmaceuticals Inc (ELTP)

[toybaby]

2 more weeks for me to SWEAT it OUT, Hope it goes well and fast for ALL Of US !!

[whatdoyouseek]

Hi lasers, I don't want to be negative, but some companies have received 3 month extension notices a couple of weeks prior to their PDUFA deadline. That could happen to ELTP, couldn't it. I am long as you know. I never flip. I just want to be realistic.

[no2koolaid]

As you recall, there is the following from the FDA...

Here are a few other ways we assess our contributions to last year’s approvals:

Under the Prescription Drug User Fee Act (PDUFA), sponsors pay fees when they submit a product application. This money is used to provide FDA with additional resources to meet performance goals, such as a goal date for completing its review of the application. In 2014, CDER acted on or before the PDUFA goal date for 40 (98%) of the 41 novel new drugs approved.

CDER approved more than three-quarters — 32 (78%) — of the 41 novel new drugs on the “first cycle” of review, meaning without requests for additional information that would delay approval and lead to another cycle of review. (DOES THIS NOT IMPLY NO ADCOM IN MORE THAN THREE-QUARTERS?)

There is every reason to believe the decision on ELI200 will come before the PDUFA date. Likely as not, the next thing they here from the FDA is - CONGRATULATIONS!