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Re: None

Tuesday, 11/30/2021 6:58:34 PM

Tuesday, November 30, 2021 6:58:34 PM

Post# of 44690
**** INTERESTING QUESTION*****

FDA GUIDELINES.... WHAT SAY YOU DR DECEIT????

WE ARE PAST 30 DAYS!!! ALSO WHY REQUEST A MEETING THEN LEAD PEOPLE TO BELIEVE THERE ARE NO PROBLEMS WITH EUA?? THEN SAY YOU WERE SURPRISED BY EUA DENIAL... UM DID YOU NOT ALREADY REQUEST DENIAL MEETING??

Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request.

JON..... WHY WAS THE PRODUCT “stalled” WHEN YOU REQUESTED THE MEETING THE LAST WEEK OF OCTOBER????

BUT THEN YOU SAY DAYS LATER TO SHAREHOLDERS THAT EUA IS PENDING (MISLEADING LIKE NOTHING IS WRONG)

A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. Examples of a Type A meeting include:
• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in 3 the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level
• Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed
• Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment