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Re: Roman516 post# 797838

Saturday, 11/15/2025 11:40:14 AM

Saturday, November 15, 2025 11:40:14 AM

Post# of 822893

It looks like NWNO had completed the clean room "C" but additional (e) New IMPD and New IND. and are hopefully completed soon?


No. The milestone completed in Q1 you note was:

(d) Technology Transfer: Clean Room Implementation.

After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms..


This is the Direct restart. The choice of system is TTF (the system from 15 years ago) or a commercially available system. It is NOT Eden.

As it is not Eden, there is no need of the new C cleanrooms, not do we even know if the "simplified" cleanrooms planned are even sufficient for Direct.

As far as the new IND for Direct, one would think it could not be far away as they were supposed to start trial(s) in H1.
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