Thursday, January 16, 2025 11:22:45 AM
flipper44,
This whole question about size of a BLA or MAA was described as a massive undertaking that NWBO was not prepared to do several years ago by the bears. Now the size of it is being used to hint at an extended delay in adjudication for the purpose of approval. Your points are valid and manibiotech went on to clarify what AI was indicating which was that there can be an extensive range but that the bigger numbers aren’t as common. Bottom line is that a well put together application, though large, will still be reviewed timely and certain parts are much more critical than others to actually pay closer attention to. Best wishes.
This whole question about size of a BLA or MAA was described as a massive undertaking that NWBO was not prepared to do several years ago by the bears. Now the size of it is being used to hint at an extended delay in adjudication for the purpose of approval. Your points are valid and manibiotech went on to clarify what AI was indicating which was that there can be an extensive range but that the bigger numbers aren’t as common. Bottom line is that a well put together application, though large, will still be reviewed timely and certain parts are much more critical than others to actually pay closer attention to. Best wishes.
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