MSB to dispute FDA finding in Type A meeting, page-391

Thanks for all your research and thoughts everyone. It made for interesting reading over the weekend!

I'm increasingly of the view that the FDA does not want to sign off on the first Stem Cell treatment without it meeting their Gold standard, regardless of the indication it is intended for (high mortality, unmet need for kids under 12 etc.) The CRL allows them to kick approval down the road for a few months, by which time they should know more about the three P3 Gold standard trial results MSB has in the pipeline. We only need ONE of these to get the tick of approval (probably ARDS) for the FDA to have satisfied their criteria, after which the treatment can be used off-label to treat sr-GVHD as I understand it, supplying more proof of efficacy, potency, batch consistency etc. (Coincidently, the election should be over by then. One can only hope )

The FDA clearly thinks the delay is warranted in order to get what it wants - a Gold standard first approval, a guaranteed P4 trial in adult AGVHD, and their backsides covered (keeping in mind they have to live with the final decision, which will change the landscape of medicine for good imo.) Meanwhile, Mesoblast get their first product into the market (which at this stage will be 10,000 doses for the first six months) and can build from there with an extra moat.

Like everybody, I am extremely annoyed by the officious politics and bureaucracy involved, and most of all the delay for the children who need this. Personally, I can wait a little longer as an investor, and I hope MSB will keep supplying the children in need through compassionate use while they await full approval.