RE:RE:RE:RE:For those of you longs You might be right about pre-BTD and BTD submissions...
The 10/16 update stated:
Theralase® is currently working with its clinical study sites in Canada and the United States to compile information requested by the Food and Drug Administration ("") for re-submission of a pre-Break Through Designation ("").
Then yesterday (10/23) we get the news about optimizing the Study II treatment regime.
Presumably, the idea is to maximize the CR numbers prior to "re-submission" for BTD, which would mean they will need to wait for additional treatments and subsequent patient evaluations to be able to include that new optimized data, right?
Does that add months (how many?) to the BTD timeline? Also, how to account for the new request by FDA to follow up and submit data even past 450 days? Is >450-day data now
required for BTD consideration, or just nice to have?