MSB 0.00% $1.10 mesoblast limited

CEO Itescu needs to go, page-158

  1. 4,443 Posts.
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    Lol, lots of long wordy posts, some of them have content within which falls into the realms of fantasy.

    Accordingly, tread carefully mums/dads/newbies as this is an extremely speculative biotech investment, DYOR and IMO you should only put in what you can afford/prepared to lose.

    Good luck to those already in, especially those drawn in by "long wordy posts" in the past, you have some difficult decisions to make.

    Anyway, here's a fact to cogitate on, previously "FDA requested an additional trial...the company ignored that recommendation" LINK, to a simpleton like me that suggests the way forward now for MSB and FDA is the same.

    Why, well FDA Commissioner Califf can explain:

    “I think it's so important that people understand this, the FDA is the only regulatory agency that gets a copy of the raw data set and does its own analysis of the data. One of the early lessons for me, serving on FDA advisory committees, was how often the analysis, when you had all the data, drew you to a somewhat different conclusion...So, this independent analysis is a critical function at FDA...”

    Of course, SI and Krause knew about this "raw data set" requirement and the recommendation by FDA to do a trial and present the data but tried to be tricky and circumnavigate it. (It was also said here ad nauseam by a few smart naysayers but it didn't fit the narrative lol.)

    Appears to me nothing's changed, they still need to do a trial and present the "raw data set".

    Good luck all.
 
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