Elite Pharmaceuticals Inc (ELTP)

[RLSJ84]

I'm here to admit I was wrong about the approval. But I've been here before with SOMX and within 2 to 3 months they got their approval. They got a CRL and then fixed their discrepancies and won approval. This isn't over. I've got money invested that I'm not willing to lose.

Since we know nothing as to why a CRL was given all we can do is speculate for what reason it was given. Labeling best case scenario. Maybe pediatric study? Hence the 10K/a.

Don't know. But I have been here before with SOMX and learned not to sell your shares because approval is still in reach. There are still positives to look at. Priority review, waiver of fee, no adcom. If it WAS the technology and poor design then an ADCOM would have been needed. Safety and efficacy again adcom needed. So maybe they wanted best label and how they worded their application FDA said no it needs revision. So one can only guess what it was for and why.

But ELTP is not done.