Hi @Wilba32,
re " I wonder if a 9-1 vote in favour of the product has ever received 2 CRLs?", you're a thoughtful researcher.
So, I thought you'd appreciate the below extract taken from Mesoblast Ltd's Amended Defence filed 16/02/2024 (File Number: VID268/2022/ Federal Court of Australia):
These are pleaded as particulars of fact - not as questions of law to be determined by the Federal Court judge. It will be a very simple and straight-forward matter for Mesoblast Ltd to 'demonstrate' that the Applicants have made a mistake in not disclosing this background to the Federal Court as the truth of the matter.
Not only has there not been a 9-1 vote in favour of a product that has received 2 CRLs in the 14 years prior to August 2020, but also
there has not even been a 9-1 vote in favour of a product that did not receive FDA approval of the therapy.
In relation to Mesoblast Ltd, the FDA still have a lot of explaining to do, IMO. But I'll excuse them that chore when they offer Mesoblast the full standard approval for RYONCIL which it is owed.
Cheers, & have a good one
Hi @Wilba32,re " I wonder if a 9-1 vote in favour of the product...
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