Regulatory Pathways - where we stand with the FDA, page-11

Oh Can_Cans a couple of months ago your criticisms may have been founded, but it appears you struggle to read:

GVHD:

”As part of this process, Mesoblast recently met with the FDA’s Center for Biologics Evaluation and Research (CBER). Following CBER’s recommendation after this meeting, Mesoblast as a next step will discuss with CBER’s review team at the Office of Tissue and Advanced Therapies (OTAT) our approach to address certain outstanding chemistry, manufacturing and controls (CMC) items, including potency assay validation.” (3 June)

CLBP:

“Mesoblast has filed a request and expects to hold a Type C meeting with the US Food & Drug Administration (FDA) during the current quarter to discuss the pathway to US regulatory approval for rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic inflammatory back pain due to degenerative disc disease.” (1 July)

C-19 ARDS:

"Recently published guidance to industry by the U.S. Food and Drug Administration (FDA) has recommended demonstration of mortality benefit for at least 60 days in critically ill patients. Mesoblast will be meeting shortly with the FDA to discuss the durable mortality reduction seen in patients under 65 years old who received remestemcel-L in this randomized controlled trial, and the regulatory pathway for remestemcel-L in this patient population." (19 July)CHF:

Now if you wanted to make that criticism for CHF, that would be fine (though I'd counter because MSB is probably talking to potential thrid party partners first). This was meant to be a good informative post only, but you have to sow disinformation don't you? In one out of four pathways OCC has already met with the FDA and is about to have further meetings and in another two, meetings are formally imminent.