Clearly it was not "such an absurd thing" as you b
Post# of 155125
(Total Views: 1036)
Posted On: 09/30/2019 6:42:43 PM
Clearly it was not "such an absurd thing" as you bluntly state, otherwise NP wouldn't be receiving advice CURRENTLY, against submitting for BTD.
If we wanted to receive BTD we should have filed months ago...which would already be very late in the process for approval. If FDA said we can reduce stability data they require from 6 months down to 3 months (which is amazing they agreed to that), and the 3 months of stability data could be provided to the FDA by end of November, then how will spending precious time submitting a BTD request help if it takes 60 days to respond to BTD? That puts us at end of November assuming the BTD is filed tomorrow, or into December already if after tomorrow. So it is already to late to receive benefit from it. Waiting for a response to a BTD request will take longer than the 3 months of stability data FDA is wanting.
If we wanted to receive BTD we should have filed months ago...which would already be very late in the process for approval. If FDA said we can reduce stability data they require from 6 months down to 3 months (which is amazing they agreed to that), and the 3 months of stability data could be provided to the FDA by end of November, then how will spending precious time submitting a BTD request help if it takes 60 days to respond to BTD? That puts us at end of November assuming the BTD is filed tomorrow, or into December already if after tomorrow. So it is already to late to receive benefit from it. Waiting for a response to a BTD request will take longer than the 3 months of stability data FDA is wanting.
(1)
(0)