They have a habit of waiting for the meeting minutes before making any announcement, so it’s still too early to expect one this week, if the meeting only took place last week.
Remember that from the guidance given in early 2024 by the FDA re Revascor use in end stage LVAD patients, the company has now been positioning since the start of 2025 for a slightly different form of use in Stage 2 and 3 patients as well. This means that the discussion last month would have been quite a substantive one and not simply revisiting what the agency had already guided the company on with some extra details. The agency should be expected, under these circumstances, to maybe want more time than just providing further guidance in the recebt meeting, in order to come up with a position re the expanded request. I imagine the recent meeting to have been quite interactive, based on much greater depth of info than available last year. Remember, they managed another publication of the DREAM trial results on stage 2 & 3 patients in Europe only late last year (following the publication in the seminal US-equivalent cardiology journal previously).
The meeting minutes are required to come out within 30 days of any meeting.
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(20min delay)