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
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