There's no doubt here. Absolutely zero uncertainty, IMO.
If MSB holders logon & listen to the audio of the Mesoblast Financial Results & Operational Update of August 31 2023 on the Mesoblast Ltd website - link here - you'll have this detail for yourself. You'll need to fast forward through the presentation to 41minutes & 22 seconds in, at which point Dr Krause very clearly enunciates that:
" ...the CRL did not question the efficacy of the product.. "
The brokerage house transcripts circulated in September 2023 were poorly transcribed, apparently by an ill-trained bot as @nippy noted. No investor should rely on them as verified.
Speaking of ill-trained bots, the significance to MSB investors of any FDA CRL is not comparable with another poster's allegorical tale of an alleged hen-pecking partner going over and over an imaginary list. It is an extremely valuable piece of commercial information.
Absolutely every biotech in the world would love to receive a CRL. You're shocked at the thought, I speculate. Why, why would that be so?
Well, provided you did not have to spend 1 cent in getting that CRL, what the FDA has just given you is purest gold. Because, in administrative law & regulatory terms, it's nothing less than a blueprint to a licence to print money
To understand you'll need to read this extract from the Federal laws in the USA, specific extracts from which I've highlighted below:
Link here. The words I've highlighted in yellow make clear that ALL MATTERS relevant to the FDA's decision to grant marketing approval for an applied-for product MUST be recorded by the FDA in the CRL, and equally importantly that the FDA has an enforceable LEGAL OBLIGATION i.e. a duty to go further and at least recommend actions that might lead to approval. If the FDA doesn't set out a matter seriously relevant to its decision - like unsatisfactory evidence of efficacy - in a CRL, it would face legal consequences and so would the officers involved. The obligations are all on the FDA under ss314.110(a).
Yes, it's not approval at that point in time, but far from being bad news, a CRL is guidance of the very 'next best' kind. And it comes from the FDA voluntarily. No-one writes it for them.
So, when Dr Krause MD (former Deputy Director of the Office of Vaccines Research & Review and WHO Vaccines Task Force member) says that:
" ...the CRL did not question the efficacy of the product.. "
we should all be jumping up & down, or at least smiling quietly, IMO.
Finally, even if you or I did have to spend more than 1 cent to be the one and only person in the world who is given this blueprint by the FDA i.e. to the licence to print money, well it's still a blueprint! And what's that worth?
That's not showbusiness foks....it's the biotech business, and presumably the reason that you're here. Now lets see what those hen-pecking non-holders try next. Actually, lets not.
Cheers, and GLTAH A great day to be alive - hi Reg.
(20min delay)