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jfmcrr

03/16/21 5:03 PM

#329850 RE: lizzy241 #329849

n sleven, yes I understand if they have 180 days to launch that would bring them into the end of feb approx. Maybe FDA has correspondence but hasn't made it public. I'll keep searching.




Maybe it doesn't exist. If they did not send it...

Is there a tracking procedure?

Does the absence of the letter set a flag?

Is there an enforcement procedure?

Would an official letter to the FDA citing "C19" issues lead to the acceptance of the required letter past the deadline?

Does it matter in the larger sense?

We'll know by next year, if not next week....