Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Dianne Will, Wrong Again

Furthermore, here is ELTP IR Diane Will's response to my question regarding the FDA's approval of the Phase III protocol:

Quote:

The answer to your question is a company could not move forward with a Phase III clinical trial protocol without FDA approval.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf

It is the sponsor’s responsibility to outline the purpose of the meeting in the meeting request. The sponsor should provide adequate and relevant information in the briefing document to support the purpose of the meeting. After a meeting is requested and granted, CDER should remind sponsors that it is their responsibility to provide additional detail about the purpose of the meeting in the meeting briefing document. The sponsor generally asks whether specific studies or trials, clinical or nonclinical, will be sufficient in design and quality to support the drug development stage discussed at the meeting. There may be other purposes, such as discussion and planning for risk management of an identified safety concern.

As one would expect from Dianne Will, a dismissive response unencumbered by any basis of true fact. The only absolute requirement for an end of phase 2 meeting would be if co. is requesting SPA (special protocol assessment). Otherwise it is entiely up to co. to request meeting with FDA and ask specific questions about their protocol(s). In theory, after submitting IND and getting FDA Go Ahead after 30 day review, a company could go through phases 1,2, and 3 and submit NDA without ever requesting a meeting with FDA or getting any commentary from FDA re: protocols. Would likely be a big waste of time & money, but nonetheless, it is untrue that FDA approval of Phase 3 protocol is requirement to begin Phase 3 trial, unless there is a SPA request. It may be strongly advised, but a company could conduct a Phase 3 trial without FDA approval of the protocol.

Again, Dianne, if you don't know the answer, it's okay to look it up before you reply. You continue to show disrespect to ELTP shareholders with untrue, condescending answers like this.