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Re: MiamiGent post# 13950

Monday, 06/12/2017 7:59:18 PM

Monday, June 12, 2017 7:59:18 PM

Post# of 40484
uh hello >> getting to phase 3 is proof that the science is there so your statement "the science is not there" is clearly false imo as it would make absolutely no sense to waste time/money if the science is not there!! lol

"...After an IND is approved, the next steps are clinical phases 1, 2, and 3, which require approximately 1, 2, and 3 years,

Phase 1 studies focus on the safety and pharmacology of a compound.[11] During this stage low doses of a compound are administered to a small group of healthy volunteers

Phase 2 studies examine the effectiveness of a compound. To avoid unnecessarily exposing a human volunteer to a potentially harmful substance, studies are based on an analysis of the fewest volunteers needed to provide sufficient statistical power to determine efficacy.

Phase 3 trials are the final step before seeking FDA approval. During phase 3, researchers try to confirm previous findings in a larger population. These studies usually last from 2 to 10 years

If a drug survives the clinical trials, an NDA is submitted to the FDA..." http://www.medscape.com/viewarticle/405869_4


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