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exwannabe

04/26/23 2:24 PM

#588809 RE: hyperopia #588746

Do not forget what LP said at the ASM re Eden:

.I'm happy to say we feel that we've made considerable progress. Again, just to give you a flavor of it, we've tested multiple versions of the system. We've tested versions that had high rate, high flow perfusion of the culture and media. We've tested low flow or slow rate of perfusion. We've tested static cultures, all of which is to reach specifications about the yield of these products made through the automated system.



During 2023, the Company anticipates that additional key areas of focus will include:
...
continued development of the Flaskworks system, including choice of the system version to take forward;


Sounds like as of a few months ago they were busy trying major process changes to see what works best.

Not only does that mean they have significant work to go, but it means they have a major process change and that makes the comparability study a challenging issue.
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dmb2

04/26/23 8:18 PM

#588899 RE: hyperopia #588746

hyperopia, thx, a very logical and probable status with a sound regulatory plan. I have seen such decisions made when applications are being strategized and typically the safe approach is taken, typically without the process change initially due to potential for delay.
It is the elapsed time element that has me being more aggressive in my hopes but that plan works, even if it may take a little more time to execute.

GLTA