Replies to post #460 on Aeolus Pharmaceuticals (AOLS)

[Sheep]

Now that I have reread everything, I don't think there is anything we are expecting from the FDA at the 60 day mark. As I read it we already got fast track designation.

https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

It looks like the phase we are in now is:

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

The PR read "Aeolus Announces FDA Fast Track Designation Granted to AEOL 10150 for Treatment of Patients With Lung Acute Radiation Syndrome Following a Radiologial or Nuclear Event"