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The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

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enkayess

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13/03/24

10:59

Post #: 72861692
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Originally posted by Wanderdog: ↑

One other question, and thanks for those that replied, after the trial, which I see may be shortened from the traditional 3 years to less, PAA then produce the final report even if the trial is stopped short from good preliminary results, PAA still have to produce the report to the FDA for fast track approval? This report takes 6 months, then there is a 6 month review period by the FDA. This is still an additional year. I am trying to develop a timeline until we are on the shelf.

Our CEO has stated that the trial should start in the 3rd quarter of this year. This is a Phase 2 study, as that is what comes after the Phase 1 study, but if it shows promising results which look like it will, then this can be rolled into the Phase 3 study? Can it be called a Phase 2/3 study already, I know our CEO calls it that but I do want to see the FDA call it that from the outset but cannot see where they have at present, until during the Phase 2 study when preliminary results are reported on.

Please don't interpret this wrong as I hold PAA, but timeframes are becoming a little optimistic from my knowledge of this sector but happy to be corrected. Timeframes are as below:

Submission of methodology proposal for Phase 2 trail, PAA state from 6-9 months time this will be delivered to FDA.
FDA acceptance of methodology of trial - 3 months
Phase 2 averages 6 months to 2 years, plus FDA review period of 6 months.
Phase 3 averages 2 to 3 years, plus submission of data 6 months, plus FDA review period of 6 months.

time to on the shelf - June 2026 best case, standard case scenario June 2029

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The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

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The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

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