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arvitar

08/27/16 10:38 AM

#123897 RE: BioChica #123896

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

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Steady_T

08/27/16 12:27 PM

#123901 RE: BioChica #123896

How do you complete toxicology if the drug hasn't been selected?
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Its_lose_not_loose

08/27/16 2:11 PM

#123903 RE: BioChica #123896

They should have [sic] drug selection by EOY, during which toxicology should be completed.



What indicators have led you to believe this will occur by EOY?