It does seem problematic....however I think we are somewhere in this process. I wish I knew. If it is then we would be told when all the fundamental FDA requirements are complete and the FDA starts its approval process.
I don't think the drug approval processes are as rigid as one might think. Impossible to manage an approval process with precision with imprecise data. Here's an outlook.
Every theory posted recently requires proof of adequate manufacturing capability. Charles Rivers Labs/Cognate is well ahead of Sawston in that regard and building out further ASAP. In one form or another both contractors had to be made aware of the need. Charles Rivers Labs will have news ready before the time Sawston does but I would not be surprised if they announce at near the same time. I also think you underestimate the folks involved and their motivation to get this whole process of validation done. Build out at Sawston will move ahead quickly once NWBO has money to work with but NWBO could not wait and Charles Rivers Labs obviously became the default supplier for expected excess demand. Best wishes.
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