$RVVTF .178 I STRONGLY CAUTION AGAINST PUTTING SEL
Post# of 40255
TRUST ME, THERE IS PRESSURE TO GET THERAPEUTICS OUT ASAP. FORTUNATELY, WE ARE SITTING IN CAT BIRD SEAT WITH FDA HOLDING OUR HAND THRU COVID-19 PHASE 3 PROCESS.
"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions."
"A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met"
PLEASE BE PATIENT...WONT BE MUCH LONGER BEFORE PPS CATCHES UP WITH WHAT I CONSIDER EMINENT APPROVAL OF "BUCILLAMINE"