2024 Here we go again., page-848

Agreed. Simply put, it’s called neutering.

The “you know who’s” should be fully aware of the negative surprise (from their point of view of course) that could emanate from a 2 month review period instead of 6-month one being given by the FDA upon resubmission.

On the other hand, acceptance of the GVHD work by the FDA as a complete resubmission alone would do much to assure the market that the company is moving closer to being able to schedule the pre-BLA meeting on heart. (I heard previously that the regulator was holding off the meeting on heart, the one that eventually happened in the first quarter of this year, because it wanted the GVHD “stuff” to be out of the way. Maybe there’s some unwritten internal operating process “rules” around workflow management in regard to dealing with sponsors of multiple product indications?)