Thanks. I came to a similar theoretical conclusion of flaskworks approximately seven to twelve months behind manual certification process, but your conversation (I missed your post when it initially came out) confirms that guess was close.
I primarily based my guess upon practice run timing difference between manual versus Flaskwork’s. Your post adds a bit of a bright note that dual track practice runs with flaskworks side-by-side with manual definitely started before first special batch completion was announced by PR for Sawston. At least two months earlier.
While I am not wise about the ways of business, it seems to me that ten month lag could potentially improve if, if, if, did I say if MHRA does not delay the certification application once it is received.
I’d imagine just like NWBO did for manual cert, NWBO will announce when they apply for Flaskwork’s cert.
Manual was applied for last May, and it was initially hoped to be granted by September 2021 (but MHRA was short staffed)
Flaskwork’s cert could be (as we now hear) applied for sometime near or around April/May 2022. That would mean, if the above follows, Flaskwork’s Cert could be granted by August/Sept 2022.
From my perspective (in hindsight), assuming results are successful, the bottleneck since possibly as far back as December 2014 was probably automated closed system manufacturing. That issue may no longer exist by August 2022.
What this might mean for TLD/Publication in the near term is anyone’s guess (since we don’t know the reason for continued journal delay), but think it through, once/if they announce cert application for Flaskworks in or around April/May, the public will realize commercial manufacturing ability is very very near at hand. Why hold back TLD/journal publication once the application is filed?
LP already knows trial results, and even though Bigger does not know trial results, it seems to me both are really most angst (in a good but impatient way) ridden about when commercial capacity will be up and running.
It sounds like we’re possibly looking at August/Sept for that final cert. if all goes well, and first commercial batches around two months later — assuming approval.
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