For passers-by, the company will be combining Dr Perin's data in class 2 and 3 patients with separate data from a randomized trial in patients with end-stage CHF (ie class 4). Upcoming meeting with the FDA. Accelerated approval for HFrEF or a major partnership announcement are possible. The company has all rights (ex-China where there's an existing partnership). This is all separate from the BLA re-submission for GvHD announced yesterday. So, two imminent shots on goal with the FDA.
Aloha.
DREAM HF Trial Video, page-61
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