RE:RE:RE:RE:RE:Next 90 Day Time ClockOn the FDA site under Fast Track....(Rolling Review).
(Quote) Rolling review, which means that a drug company can submit completed sections of its Biological Licence Application(BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every sections of the NDA is completed before the entire application can be reviewed.(End of Quote)
https://fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track The big question is what does
completed section mean.
Rumpl3StiltSkin wrote: Eoganacht wrote: Your guess is as good as mine, but the way I took it is that they plan to submit data on the first 25 when patient 25 gets to 450 days after his first treatment - 360 days after his 90 day assessment. But by that time they will have treated many more patients as well, and these patients will have data - some will have 360 day data, some 270 day data, some 180 etc. If they submit this data along with that of the first 25 they may be able to make a stronger case.
Kingpin68 wrote:
I'm wondering about the wording here from the previous quarterly about break through designation timing: 'Theralase plans to compile up to the 90, 180, 270, 360 and 450 day assessment data (urine cytology and cystoscopy) for these patients with the intent of submitting this interim data to the FDA for consideration of Breakthrough Designation (BTD) approval.' The use of the word 'interim' data may suggest they are not go to wait one year after the 90 day data.(?) If they wait and submit results at 450 days for all patients, then that isn't interim data at that point is it ? Thoughts?
Hello Gents and happy weekend,
I dunno why I think this, but I thought BTD could come anytime, as long as study 2 is going well, what happens at 450 days, I think is TLT's application for Accelerated Approval. BTD would be a very good indication that AA will happen, as long as the data contines to come in good for study 2. Am I crazy? :-O