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Re: GVX808 post# 16223

Thursday, 09/22/2022 12:15:41 AM

Thursday, September 22, 2022 12:15:41 AM

Post# of 16699
"Although there is no regulatory review deadline for these products, the FDA currently aims to review 75% of all orphan designation requests within 90 days of receipt. In her recent blog post, Dr. Rao states that the Agency strives “to review these requests in an efficient and timely manner because we understand how critical designation can be for companies to move forward with their drug development plans.” Dr. Rao notes that reviewing ODD applications in both an efficient and timely manner is still a top priority within the OOPD, “but to ensure we continue to conduct these reviews with the appropriate level of care and consideration, our current goal is to review on average 75% of designation requests within 120 days of receipt.”

So, possibly AGN will get an ODD answer by the EOY.
With Ifenprodil IPF/CC Clinical Trial history in Australia/NZ hospitals and the refunds AGN has benefited from, there seems to be a good chance the AGN.aus subsidiary, (with Dr Williams) might be the logical place for further work.

So#2, that may imply with the Now faster progress the DMT/Stroke research program is finally seeing, AGN might have BOTH of these Drugs' Trials dramatically moving forward by EOY.

Hmmmm. JMHO...GLTA...