Elite Pharmaceuticals Inc (ELTP)

[freegriff]

ya, I'm worried. 3 things: having no adcom when many expected one, Nasrat saying 2-3 years to NASDAQ which seems too conservative if approval imminent, and the recent LPC $ means they don't know but they're getting the feeling they might have to do some more trials.

Any number of issues could've come up in ADF trial designs etc. They were just doing their best there, there wasn't a lot of history to go off of. Thinks the results are great and easily repeatable, but FDA can be nitpicky (not to mention corrupt) when it comes to how they're done. Blaim Camargo, who cares, they may just want more. I hoped the FDA guy we added would help deal with them, but I'm looking for a PR tomorrow morning pre market or I'm decreasing my non long shares.

I don't think we're ruined, but would not be surprised to learn we must wait another 6 months. If we get CRL tomorrow, it'll be 30 days til we can meet with FDA to get started again, another probably month or so to get the ball rolling, then time for study completion, then resubmission with faster review.

Of course, that means additional costs. As responsible managers they've prepared for it and been very up front this may not happen as we all like tomorrow.