I thought the FDA did state that MSB have not demonstrated efficacy / "effectiveness" with Remstemcel
Have I missed something?
see below
"FDA’s position is that the product attributes the Applicant
has identified as related to potency and activity, however, do not have a demonstrated
relationship to the clinical performance of specific DP lots, and that the product’s proposed
immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects
receiving remestemcel-L. Without a demonstrated relationship with clinical effectiveness and/or
in vivo potency/activity, controlling these CQAs may not be sufficient to ensure the
manufacturing process consistently produces remestemcel-L lots of acceptable quality"
Why do people say restemcel is proven to work? do we have data from how it is going in Japan? Or why did SI not have data from the US to show it works
The above reasoning is why I feel the market has dropped it like a hot potato today and from the above paragraph is probably not an over reaction, like some people are saying. As to me it really looks like it is going to be turned down.
Also I'm surprised no one else has brought up why was the FDA briefing information was not announced early this morning to the whole market as price sensitive information along with a trading halt? and why has it still not been announced. I'm also surprised none of the sleuths on here picked it up this morning and obviously only the big boys did leaving mum and dad wondering what is going on?
https://www.fda.gov/media/140988/download
I really hope we get some good news now we deserve it.
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