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Posted On: 02/06/2020 1:33:23 PM
Post# of 148884
Reading through BTD FAQ on the FDA site I noticed
"Can a sponsor submit a request for breakthrough therapy designation to a pre-IND?
A sponsor should submit a request for breakthrough therapy designation with the submission of a new IND, or as an amendment to an active IND. Requests for breakthrough therapy designation should not be submitted to pre-INDs, inactive INDs, or INDs that are on partial or complete clinical hold."
Does this also imply that getting a basket trial in the works basically sets them up to apply for BTD on all indications at once since they would all be active INDs? They seem to allude to that later in the PR, but I just wanted to make sure my understanding was correct. It would seem that this may be the first in a couple of moves. I don't think this surprises any of us, but maybe the strategy is to expand the scope of the BTD?
"Can a sponsor submit a request for breakthrough therapy designation to a pre-IND?
A sponsor should submit a request for breakthrough therapy designation with the submission of a new IND, or as an amendment to an active IND. Requests for breakthrough therapy designation should not be submitted to pre-INDs, inactive INDs, or INDs that are on partial or complete clinical hold."
Does this also imply that getting a basket trial in the works basically sets them up to apply for BTD on all indications at once since they would all be active INDs? They seem to allude to that later in the PR, but I just wanted to make sure my understanding was correct. It would seem that this may be the first in a couple of moves. I don't think this surprises any of us, but maybe the strategy is to expand the scope of the BTD?
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