|
|
Post by spiro on Mar 14, 2014 17:38:00 GMT -5
|
|
|
|
Post by Chris on Mar 14, 2014 17:40:21 GMT -5
Great post, skimmed through and will read later. Thanks!
|
|
|
|
Post by StevieRay on Mar 14, 2014 18:25:10 GMT -5
“The discordance also raises the question as to whether EMDAC members are prepared to make a “yes” or “no” vote on issues as complex as benefit-risk assessment based on only a few hours of readings and deliberations.” Oh God, not another Boogeyman! I hate it when you do that, Spiro! You would only hope the FDA would provide voting members with all the necessary materials several weeks in advance of the meeting to allow ADCOM members to properly prepare for the meeting. This sounds too much like our congress where gigantic legislative bills are presented hours before an up or down vote is requested. Nobody has time to actually read the bill and are just briefed on the highlights. Considering this is the 3rd time before the FDA I would have to believe most of the voting members are at least aware of Afrezza and have done a little research on their own to form some opinion. Makes me want to prepare an Afrezza Primer and email it to all the voting members just to ensure they have all the facts before making a decision. |
|
