MSB Trading 2020 - a new dawn, page-10476

You know what ticks me off " The Bloody FDA"
I just read @Moreforme's post # 49040567 see below exerts on the Type A knock back - UNBELIEVABLE Stuff.

During both the adcomm and in their CRL, regulators took issue with Mesoblast’s study design given that the company submitted its application on the basis of one, single-arm and open-label trial. In the study, Remestemcel-L demonstrated a statistically significant benefit in its primary endpoint against the historical control rate.
But because many parents and pediatricians are reluctant to risk putting children into the placebo arm of a randomized study, Mesoblast argued that key opinion leaders said an additional study was not feasible.
The veto came despite the FDA approving a similar drug — Incyte and Novartis’ Jakafi — based on one single-arm trial, something for which ODAC members chastised the FDA.

Earlier this week,
Mesoblast met with the agency for its Type A meeting, and the company reported in its third quarter earnings that it does not expect the FDA to reverse its decision for accelerated approval. Mesoblast is still waiting to receive final meeting minutes to know whether that’s indeed the case. The CRL set back potential approval in GvHD from 2021 to 2024, per analysts.


Un- Bloody Believable !!!!!!!!
ST