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flipper44

02/23/22 1:53 PM

#446251 RE: hyperopia #446247

What happened?

DI says they need Flaskwork’s practice runs in parallel with manual specials runs (apparently) in Sawston.

Sawston was supposed to start first specials run before Sept 22 2021, but this didn’t happen until February 17, 2022.

That set Flaskwork’s PQ back by five months at best, that is if they needed the parallel runs to be at Sawston.

For manual, it took at least from March 16 to February 17 to go from practice runs to first specials patient at Sawston.

There were MHRA delays, so that could have caused about three to five months damage to get to first patient.

At best Flaskwork’s is seven months out, not because they had not done the other _q stages ahead of pq, but because they were left waiting until February 17 to start practice runs which they earlier thought would start in late summer 2021.

Part of Flaskwork’s delay is definitely due to earlier MHRA delays on manual. Hopefully Advent Sawston is a higher priority for MHRA this time around.

Imho.





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biosectinvestor

02/23/22 2:06 PM

#446257 RE: hyperopia #446247

I am sorry hyperopia where are you seeing that practice runs won’t start until summer with Flaskworks. That is not my understanding of where they are nor do I see that in the press releases. I suspect there is some extra language in there coming from some other source and if you could be more specific as to the source, that would be most appreciated.

I also do not think that anything is currently waiting for Flaskworks.