FDA has given Meso a pathway to approval from potency assays which could be completed by Jan 15. Then if it is a Class 1 resubmission it could take FDA 2 months to consider the assays. They aren't completely new assays nor a new MOA, they will just be showing that the inventory and future production can match the potency of GVHD001.If if FDA decide it is a Class 2 resubmission and take 6 months, the question is not whether approval will eventually come, but how will the cash runway extend until approval and commercial sales.SI is very confident of this, but it is the most important question for the AGM in 2 days, and if there is a well formed strategy which could avoid a capital raise at these prices, then Meso should go into detail as to how they plan to execute it.More info would be a great benefit to confidence and the share price.
Share price is a Joke.
Aloha.
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