News Focus
News Focus
icon url

biosectinvestor

05/02/21 7:52 AM

#373922 RE: ahp123 #373921

If it had been pseudoprogression, why is it that only placebo patients are missing from the total number and there was no update to the consent. A regulator and a company would have no reason to keep the cause secret if it were a worry for the well-being of any of the patients, they would, in fact, by legal necessity, make it public information.

I did not say you said anything about crossover or what I said, I simply said there were other ways to see the issues you seem to be excited about and that a redo seems unlikely.
icon url

iwasadiver

05/02/21 9:39 AM

#373947 RE: ahp123 #373921

I’m not sure where you’re getting your ideas about not allowing comparisons to Historical Controls (HC), but you’re wrong. Regulatory agencies, including the FDA, allow use of HC in situations where it’s a rare disease with little or no approved treatments that extend beyond the SOC, when the disease course is highly predictable and the treatment is showing dramatic results in comparison, where the endpoints are easily Objective (OS) and the impact of variables associated with treatment and baseline are well established...i.e. there’s plenty of data out there from other trials as well as real life data.

You have every right to be nervous about all of this but your seemingly indignant dismissal of allowing comparisons to Historical Controls isn’t being objective at all in my opinion.