@flyingmango
i should have clarified, if the CRL is based on the manufacturing process, or things that can be explained within weeks with satisfactory result then yes i think that its ok.
if the CRL is issued based on efficacy, safety, etc, things that directly affect the product being approved (and not logistical issues) then yes definitely i agree with you that it would be devastating, sorry, i should have explained my presumption on the CRL!
as @LJohn stated "it's more issues that need to be resolved around data/manufacturing etc. More likely it will be something that may be able to be resolved in 1-3 months, but I don't think it will be unresolvable" this is what my understanding is about CRL's.
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