manufacturing is currently our Achilles heel
And I think that is speculation too
Lonza have 19 production sites in the USA, some of those might be able to step up quickly, the issue is WE do not know. I'd be quite certain Lonza, the FDA and also Mesoblast have very good intelligence on the matter, and have had for a few months at least.
Nor do we know who else Mesoblast have been talking to regarding alternative supply in the US. Nor the capability of supply increase of any new technology the FDA might agree to the use of in the current situation, not limited to 3D bioreactors.
The easiest analogy is, under the current signed directive this is the biological equivalent of a war footing, medical countermeasures are urgent. Normal liability is waived for some things, decisions, with the data available, are made by a committee of people who are as close to expert as they can be so that a response can happen sooner rather than much later.
And, yes the inability to supply will rule out a solution, it is there in black and white, and that is why I think many discussions have been going on, for some time, probably how the amount for the last CR was arrived at.
Just depends if Mesoblast will be requested to assist, and there are limitations in the rules as to what the US govt can do in that regard to. I last looked a month or so ago.
If you want to research this yourself this is a useful place to start;
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
Work your way out from there.
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