Very good thoughts...
I do think the minimally manipulated requirements need to be applied to the stem cells as the tissue is never intended to be re inserted. I agree there.
It is clear that significant changes occurred after pre-IND filing. And word now that Andrews is closing in on opinion about SVFC after evaluation makes me believe it is in response to FDA dialogue. Be aware of the seriousness and consequences of this dialogue.
If SVFC stem cell extraction method is deemed minimally manipulated or an even bypass significant portions of the IND process... Then every researcher in the country will want this safe and efficient method and then can research unencumbered by FDA a multitude of treatments for multitude of conditions. The investment dollars into those growing, culturing, expanding, utilizing enzymes is significantly at risk.. Can't underestimate the gravity of this effect.
Could be key to all this silence and caution, yet confidence in accumulation and portrayed from the top.
Could be bigger than we all imagine.. Or not. That is the risk reward speculators love.
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