The type B minutes provide the requirements to meet for Revascor approval.
If the accelerated pathway is achievable and we move down the BLA lodgement path that is fantastic news.
If the accelerated pathway is not clear then we need to run another trial to gain approval, which would likely partner but on less favourable terms.
The confirmatory trial is not really about repeating the results , as two randomised phase lll's have already shown efficacy. ( my thoughts as an investor)
A confirmatory trial will be about running a phase lll with Revascor's required CMC issues and potency assays in place as determined by the Type B minutes. As opposed to the regulatory minefield we endured getting Ryoncil approved.
I'm hallucinating that part of the Type B will be about responding to necessary changes to 3D manufacturing and what that means to meet demand if approved.
That is why I do not understand the strategy of the shorts at this time, I'm missing something but it's not my first wife.
Reg
MSB Price at posting:
$1.67 Sentiment: Buy Disclosure: Held
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