MSB - 1 step closer, 2 steps back

Well, that was undeniably a hard pill to swallow.

What are the positives and negatives to come out of that.

Positives -

• The FDA has no safety concerns.
• The FDA has no observed manufacturing concerns.
• The FDA acknowledged progress with the potency assay.
• The timeline if approved at the completion of the adult trial, will likely be the same as it would have been if children just been approved, and thereafter the same maket opportunities on the same timeline since this will now be an approval for all ages.
• I think the CRL forced the company to learn something about the effect of the treatement on high MAP and IL2Ra supression levels, that I expect will be incredibly usefull in ensuring the adult trial is a successful as it could be.

Negatives -

• Just added another 2+ years onto the GvHD treatment ( maybe 4-6? ), which will probably be beaten by CLBP ( Depending if CLBP is initiated soon ).
• SP !

Redemption

• In my opinion, the company need to get these next 2 trials running as fast as physically possible. Particularly the CLBP trial. It's the blockbuster which has the most consistent results. I hope to god they announce on Monday that recruitment has started. If it is simply more data the FDA want, there is absolutely no reason MSB need to hold up CLBP for SRGvhD.
• the irony of the press release from Mesoblast...... Last CRL the FDA recommended a trial to demonstrate efficacy...... Now the FDA want more data with no mention of a trial.... and it's MSB doing a trial. I wonder if this has something to do with trying to validate the MAP score.