Biotech Values

[murocman]

Thank you for the input. I guess I go back to my orIginal question then.

If the endpoints are clinically insignificant, why would the FDA allow trials to be completed, accept an NDA, and then a month before the PDUFA, say that we think you have a clinically insignificant drug?

I know this same issue happens a lot with cancer drugs touting PFS vice OS endpoints and I know the FDA has basically said OS should be the yardstick.

It just seems like waste of everyone’s time and a heck of a lot of money. There is also at least the appearance to the outsider that the company was misled on the validity of their approach

Murocman