Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Okay, you raise some valid points (I am being honest, so do not think it is a set up). With FDA experience you know that precedent does matter and I agree. It has long been an issue for smaller firms to get the face time and approvals. In fact, there are times when the bigger companies are able to play politics within the FDA and stall some companies efforts at approval. However, and please correct me if I am wrong, the issues you mentioned about the need for efficacy trials are not related to 505b2 submittals. Again, based on my understanding, the reason the trials are not a given (I did not say will not be required, but only that it is not apparent they are needed), is because of the nature of the compound that would be submitted.