Hold on. Remember the scheduled meeting with the FDA to discuss a pathway to approval for CLBP and Heart Failure, the meeting that everyone was convinced would lead to "AA" (as in "accelerated approval") for Heart Failure??
Well the good news is, it's happened already and it was "productive". And the bad news is it wasn't productive enough for the company to share the results with investors...
"We have also had very productive discussions with the FDA regarding potential approval pathways for our second generation rexlemestrocel-L in late stage development for the treatment of chronic low back pain (CLBP) associiated with degenerative disc disease (DDD) and for heart failure patients with reduced ejection fraction (HFrEF)"
Remember way back when "second generation rexlemestrocel-L in late stage development for the treatment of chronic low back pain (CLBP)" was actually meant to repair the Degenerative Disc Disease (DDD) itself, not just treat the pain....
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