I also note: the comments on Yahoo Finance are also positive right now... ie:
https://au.finance.yahoo.com/quote/MESO/community/
BillandApril:
I’m confused by some of you. This seems like more of a buy than ever before. Here is the report conclusion.
StockOwner:Why people don't read:" 9 CONCLUSIONS
The remestemcel-L manufacturing process has been developed to produce a safe, effective, and
consistent product. Over development relevant quality attributes have been established that are
representative of product characteristics for identity, purity, safety, and efficacy.
The mechanism of action regarding the product’s immunomodulatory characteristics are well
defined in vitro and in vivo. The relevancy of the product’s potency marker, TNFR1 expression
levels, have been supported through in vitro data and correlation to clinical outcome measures in
the clinical efficacy studies.
Control of starting materials, raw materials, testing performed at multiple points of the
manufacturing process through in-process testing and final release testing, use of sterile single
use technology materials and a functionally closed manufacturing process, all provide assurance
that the product is safe and manufactured consistently.
The product has been well characterized through long-term stability studies demonstrating that it
maintains a shelf-life of 48 months when stored at ≤ -135°C in LN2 vapor phase. Storage and
distribution process and controls are in place to ensure product quality is maintained from the
start of production through to receipt by the customer.
In conclusion, remestemcel-L has a well-established and robust manufacturing process which
produces a product that consistently meets product quality attributes."1 hour agoI just realized something. Since the briefing document doesn't actually challenge the efficacy being claimed, and since they even took the trouble to state that just because there's really great efficacy, that doesn't mean that the production process is consistent or that the mechanism of action has been verified, it's fair to assume that the FDA is already conceding that remestemcel-L is in fact very efficacious. Since that is the case, and the disease being looked at is for children at 100% risk of death, I would say it's practically a given that remestemcel-L will in fact get approved. Ir would be the height of antiscientific insanity to stymie approval for the sake of subtle processing refinements which may not even improve survival rates beyond what remestemcel-L has already demonstrated, and amply so at that.
...
Etc
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