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reginaliberta

07/28/13 10:07 PM

#9350 RE: Doc_John #9348

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

When SBFM GETS THERE I SEE $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
IMHO
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Angel21stCentury

07/29/13 12:22 AM

#9351 RE: Doc_John #9348

HAIL BREAKTHROUGH AND SHOCK THE WORLD ADVA-27A NOVEL LEAD ANTI CANCER DRUG.
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Calabria Mia

07/29/13 1:01 AM

#9354 RE: Doc_John #9348

Start with breast cancer drug
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pijoe

07/29/13 8:02 AM

#9355 RE: Doc_John #9348

Definitely. I wish I had an idea on how long the animal toxicity trials will take or a general idea. Anyone invested in biotech long enough to gage or give an intelligent estimate on that? I hope for the sell out because it would still be a great payout and for selfish reasons obviously would mean the payoff will be a lot sooner...the end game of helping to cure a major problem is more important of course but Id still like to make some bank