FDA delay for ph 3 trial approval, page-34

In addition, I know for a fact there are a number waiting on the sidelines, they are waiting for a Greenlight, the ability for us to progress from the FDA. Until this happens we are certainly stuck. After that, there is the question of funding, how do we pay for a P3 irrespective of n coming down and hopefully somewhat less monitoring required etc .

Once that happens this thing is mightily de-risked, the entire thing will turn around. We know how consistent the data has been to this point and what the drug can do. I think there are a number of funding alternatives that will then present themselves. We will genuinely be a Phase 3 company with not just any drug on trial...a super drug, capable of a lot, capable of addressing indications like never before in time frames not seen^* and with an exemplary safety profile.


My views



* = eg. changing cartilage morphology in 6 months as an example