AI
Saturday, August 27, 2016 10:38:27 AM
That does not mitigate any of the facts I've pointed out regarding timelines and probabilities of success. Here they are again:
The company first has to identify a lead candidate for IND-enabling studies, which they have not done yet.
Before the company can begin Phase-I studies, they have to do all the chemistry and toxicology testing on that candidate, to get an approved IND application. That takes about a year in the most optimistic case, and 60%-70% of candidates fail this process.
Refer to the FDA timelines and probabilities, provided below for everyone's convenience, for an accurate estimate of how long things will take:
http://www.fdareview.org/03_drug_development.php
The company first has to identify a lead candidate for IND-enabling studies, which they have not done yet.
Before the company can begin Phase-I studies, they have to do all the chemistry and toxicology testing on that candidate, to get an approved IND application. That takes about a year in the most optimistic case, and 60%-70% of candidates fail this process.
Refer to the FDA timelines and probabilities, provided below for everyone's convenience, for an accurate estimate of how long things will take:
http://www.fdareview.org/03_drug_development.php
A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche
