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W_W

Re: None

Wednesday, 11/22/2023 8:34:51 PM

Wednesday, November 22, 2023 8:34:51 PM

Post# of 699721
The reviewing process of the Publisher/QC term for the MAA submission project is on the project critical path, it is the last action item in determining the project's completion timeline. The PR indicates that this process is well underway and currently in its final stage.

The majority of the work on the key section of the MAA has been successfully completed and delivered to the publisher. The only outstanding task is for the consultant to finalize the remaining small portion of the key section and deliver it to the publisher. Assuming this can be accomplished within that 2-3 weeks/several weeks timeframe, the submission project does not seem to be significantly delayed. Although completion in November may be questionable, there is a high probability that it will be successfully concluded in December.

The Company provided an update that most of the work has been completed on the key section of the MAA that remained to be done at the time of the prior update, as well as on required supporting documents, the majority of which have been delivered to the publisher/QC team. That team is now under way on this final stage of their work.

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