Potential 100 bagger Biotech missed by the market, page-1430

Thanks again for the detailed reply! I have just had a read through those links.

If the drug is granted fast track, the company can then apply for accelerated approval therefore clinical trials would follow a surrogate endpoint as opposed to clinical endpoints (potentially saving a lot of time) could such a thing take effect from phase 1 trials?

I’m just going to speculate for a second, but is this perhaps why so many studies (40+) have be completed before IND-enabling is completed, could that be a directive from the FDA before fast track is granted?