Jimmy, see in the press release the FDA agreed on the patient population.
That is a huge positive development because that is precisely where companies face hurdles in p3 planning.
This means the FDA is onboard with GALT’s next step and just need to iron out more of the details.
A written response is routine when the FDA does not have major concerns. In fact, if the FDA had big concerns they would want an in-person meeting to go over what their concerns are.
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