FDA just released the August 13 ODAC briefing
https://www.fda.gov/media/140988/download
Thanks for this link Tony!
Cutting through the jargon, my reading of this is that MSB face some quality assurance problems in their testing of the product, and connecting their analyses with clinical outcomes. The Americans are quite tough on this stuff. The wording suggests the Feds are open to - in fact are encouraging - different test methods, or demonstration of the product directly by clinical outcomes.
Whatever the implications, we can be sure some MSB biochemists and managers will be sweating this tonight our time. Time to pay for those expensive tests, or bring in some external experts!
This of course is my own conclusion and not financial advice - but I do want to believe in MSB, and have for some time.
FDA just released the August 13 ODAC briefing...
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