Gonia, all your questions I provided in my first post. It does require you to read it all.
After some of the 3 min sessions from each company you can see, if you read it, that then the panel members will ask for additional info.
Questions from panel 9:55-10:25
Questions from panel 12:00-1:00
Questions from panel 3:00-3:30
Questions from panel 5:00-Close: Closing statement
This is a public hearing from the FDA where panel members will listen to all about why tissues, human cells ect should or should not be regulated as a drug ect. ITS A BIG DEAL which determines final guidance.
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If they determine that this process is a drug, then your talking about millions in safety and efficacy studies before approval....
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