Monday, July 13, 2015 5:22:45 PM
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf
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.
"There are three kinds of lies: lies, damned lies, and statistics."
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