InvestorsHub Logo

Doc logic

10/26/22 11:23 AM

#524987 RE: hyperopia #524983

hyperopia,

I agree with this except that I also believe they had a contingency interim plan for artisan method use initially as a backup if results came in less stellar than expected. I believe that back up plan was jettisoned when the company saw the unblinded data and this led to the time frame we were left with before news waiting for closed system validation. It was at this point, validated by the Cognate/CRL moves, that I began the manufacturing, manufacturing, manufacturing mantra. Best wishes

hoffmann6383

10/26/22 11:27 AM

#524989 RE: hyperopia #524983

Thanks Hyperopia for the further clarification! Good stuff.

skitahoe

10/26/22 11:29 AM

#524990 RE: hyperopia #524983

Before I saw your post I was about to write one on why going to the regulators is taking so long but it is all here. I don't care how quickly you can do all the paperwork, until you have an approvable production facility you can't do a thing.

In the past I've called it the critical path and that is exactly what I believe it is. I suspect that the path may be a little shorter for the UK, but don't know that to be a fact. I think that we're close, but won't know until we have an approval.

Gary

flipper44

10/26/22 11:43 AM

#524994 RE: hyperopia #524983

Thanks.

Why do you think they needed to have about 50 per week manual capacity that will, under your hypothesis, apparently never be fully utilized, only to be leap frogged by Eden?