FDA ODAC Meeting Material discussion analysis, page-175

From Yahoo finance:

LongStock
This is a well orchestrated and coordinated "hit job" but I'm holding onto my shares.

The $34 billion-dollar a year Steroid pushers are scared and they have gone the extra mile to crush Stem Cells. Never mind that Steroids don't really help the serious grades of GvHD and that the kids will die. Remestemcel-L is their only chances to live and the the Steroids pushers are trying their hardest to take it away from them. Shame, shame as they someday stand before God.
MarketMania
I'm going to keep coming back to these TWO VERY IMPORTANT points from the FDA briefing document (see below). If Mesoblast MET THEIR PRIMARY END POINT - and the FDA helped design the trial AND there is NO SAFETY CONCERNS based on a LARGE PATIENT POPULATION - including the 10 year old Osiris' trials, then I believe they will approve. There is NO OTHER alternative for these kids. There's a lot of trials that highlight the benefits of stem cells and their mechanism of action. The human body is very complex and everyone is different - but the reduction of inflammation has and continues to be proven with the use of stem cells (even with competitors products - $ATHX, & $PSTI and others. Also with products like Grafix - Smith & Nephew, Osteocel - NuVasive, BIO4-Stryker, etc.

In addition, don't forget about the insurance coverage that already seems to be in place in certain parts of the country - seems odd that this would have taken place if there was so much doubt. IMO, the public and medical community NEEDS Remestemcel-L and the FDA will approve it!

"4.4 Summary
Protocol MSB-GVHD001 met its primary objective; the Day-28 ORR was 69.1% (95% CI: 55.2,
80.9) in the FAS. The primary endpoint results in MSB-GVHD001 were statistically significant,
the measured response was durable (median 54 days), and the results were consistent across
subpopulations and secondary efficacy endpoints. "

AND

"5.3 Summary

In general, no safety signal of concern was identified in the studies of Remestemcel-L"

DYOR, Calm down and not F advice!