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Post# of 251981
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Re: oc631 post# 251694

Saturday, 05/11/2024 5:03:44 AM

Saturday, May 11, 2024 5:03:44 AM

Post# of 251981

I suspect some developers, more specifically protein-based vaccine developers, are frontrunning this decision and are already manufacturing JN.1 COVID vaccine to give the appearance they are competitive in development time and scalability yet if there was another pandemic it would become clear they are not due to time constraints.



I need to walk back this statement. NVAX is applying for EUA and a BLA using prefilled syringes this season. A decision made to remain competitive but in turn creating uncertainty and additional risk. A small company building up a large inventory of PFS product before being granted market authorization would seem inadvisable. Yes MRNA moved to a PFS product by why not PFE? It may have more to do with fill/finish requirements than cost. Granting EUA during a controlled COVID endemic will come with much higher requirements and standards than years past. Furthermore NVAX has signed APA's with Australia and Canada so things could get messy if the company runs into delays.

Just an observation on NVAX. They filed their 10-Q and the 8-K for their earnings release yet what's notably absent is the 8-K announcing the SNY deal (as of the time of this post). Anyone care to guess why?



The terms of the deal were added into the same day 10-Q release so perhaps the company felt this would be a redundancy. Normally NVAX wouldn't be so efficient but they needed a valid reason to remove the "going concern" disclosure.

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