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Posted On: 05/01/2025 1:34:44 PM
Post# of 152417
I think out of the whole 28 patients they had to have failed at least 3 or 4 prior treatments, but these 5 survivors had all failed 4. They were in different trials that we pooled together so that may be the reason for the difference in number of failed treatments.
I am hoping that the next PR regarding mTNBC on or around ESMO announces that we've either reapplied for BTD, or even better, we've have applied (or will be applying) for Accelerated Approval with the support of the FDA.
That would likely be our fastest route to approval and with our already having Fast Track Designation could be as quick as 6-9 months maybe? ChatGPT thinks a 6 month FDA review time so it would just be how quickly we could get the application in. If they started in February when they got this data it could be submitted soon. All very wishful thinking on my part though. Excited to see what lies ahead in the next two weeks.
I am hoping that the next PR regarding mTNBC on or around ESMO announces that we've either reapplied for BTD, or even better, we've have applied (or will be applying) for Accelerated Approval with the support of the FDA.
That would likely be our fastest route to approval and with our already having Fast Track Designation could be as quick as 6-9 months maybe? ChatGPT thinks a 6 month FDA review time so it would just be how quickly we could get the application in. If they started in February when they got this data it could be submitted soon. All very wishful thinking on my part though. Excited to see what lies ahead in the next two weeks.


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