Elite Pharmaceuticals Inc (ELTP)

[freegriff]

n2k, I would really like your experienced opinion on one thing in particular.

To me, reading between the lines of the CC, knowing chemistry, and discussing the matter with a pharmacist friend, there is a slim chance FDA allows us to do a bioequivalence bridging study like last year.

What the FDA will require is uncertain, but could be expensive and time demanding because the excipient is a critical component of the product. Elite would be proposing to change a core feature of a product while relying on data gathered on a substantively different product.

If you can give me a simple answer, though one I understand has great complexity to it, what odds do you put on Elite re-submitting the NDA by EOY?