RE:RE:RE:Questions without answersconsultant99 wrote: Waiting three months will bring three patients from the 360 day scan column to the 450 day scan column. Agreed.
However the company is only going to submit the data for the first 25 patients. That 25th patient could be NR CR or PR. Getting BTD is a binary outcome based on the application - yes or no. From everything the company has been telling shareholders we meet the requirements based on the 90 day, 450 day and safety profile for the 24 patients that have been evaluated.
I assume that as the trial progresses and more data becomes available the results will continue to improve. But why wait if you don't have to?
The difference between 20% for 24 patients and 25% for 25 patients at 450 shouldn't change the FDA decision on granting BTD sooner should it?
The FDA will likely see that data on the next three patients (25,26 and 27) before they have to make a final determination on BTD even if we applied after patient 24.
But what do I know? I just have questions...
They may not wait that long, so say patient #25s data is a couple weeks away, they could submit it then, the numbers getting better only helps the cause as the FDA gives TLTs BTD a serious look.
Likewise the AA as we move into next year.