Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Answers? How about the following link? https://finance.yahoo.com/news/fda-approved-fewer-drugs-2016-140002879.html

Briefly, here is what you will see...

There was a notable dip in FDA novel drug approvals in 2016 with the agency approving 22 drugs. Compare this to 45 approvals in 2015 and 41 in 2014 and the 2016 numbers look really disappointing. And, since the number of applications submitted in 2016 remained constant, it means there was a spike in CRLs. And, they went to companies big and small, new and old, sophisticated companies with advanced pipelines and novel companies with a single drug as their lottery ticket.

What I also found fascinating in my research was this...

Forty-five percent of CRLs include comments related to specific clinical deficiencies, many of which could be addressed during the drug development process to avoid unnecessary delays in an application’s review.

So, it appears Elite is not alone. In fact, darn near half of the companies might have avoided their CRL. This shows that Elite is not much different from the other recipients of CRLs. And, according to the FDA, a CRL is not a judgment of the capability of the company receiving the CRL. It is merely an assessment of the drug submitted at that point in time. As we know, a single CRL does not mean a company cannot resubmit nor does it mean that a resubmittal will not be approved. But that is a whole other discussion for another time.