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exwannabe

08/16/25 1:27 AM

#781868 RE: manibiotech #781820

As usual , filing has left everything to speculation and imagination


No update on the MAA should have been expected. But some side issues were updated.

. It has established that the IND for a Direct trial was not submitted in Q2 as previously expected.
. It has established that Direct is not using Eden for some reason.
. It has established that the Class C cleanroom construction is expected to begin this Q (and may have already started). That puts to bed speculation/assertions the C clean rooms actually exist already.
. It has established there is no near-term plans for US manufacturing of Direct or -L

And does raise new questions that are worthy of rational debate.
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antihama

08/16/25 10:11 PM

#781982 RE: manibiotech #781820

So true!

As usual , filing has left everything to speculation and imagination

Here's one I don't believe anybody has talked about.

Potential Compassionate Use Programs in the US. The Company has had a compassionate use program in the UK for a number of years, and believes that those compassionate use cases have been helpful for the patients involved and have generated real world data that is quite useful. As previously reported, the Company is expanding its existing compassionate use program with additional clinics

I'll leave it to speculation and imagination to what that means.