Type C is open to interpretation. Good v bad is difficult to say and is based on submission. FDA have had the submission for a month, enough to interpret and respond.
Type C could indicate submission is straight forward, updated phase 2 results, EMA one study would be considered too. Going after pressure and headache and hopefully to division of Neurology. NOT to opthomology.
Type C could indicate that a simple written reply and response (maybe to grant one study only!!).
My interpretation but basing off incomplete information that no one in the market will be privy to.
This is progress is the news. And in that respect it is good.
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- Ann: Invex Granted Type C Meeting with FDA
Ann: Invex Granted Type C Meeting with FDA, page-5
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