The evidence indicates that this drug does not cause mutations in vivo but it would be useful to verify that in patients. I would advise that the company engage in post exposure monitoring for mutations in treated patients. I believe the FDA has chosen the risk mitigation approaches that they have proposed seem reasonable to me. Um I do think they should limit the use of this drug to high risk individuals. I guess the you know I'm comin I don't I think that you should not approve it for use in pregnant women. I mean benefits outweigh the rest in this case.
I feel like the potential risks and benefits. I'm assuming you can hear me Yeah I voted yes. You also may provide justification of your vote if you wish. We will now go down the list and have everyone who voted state their name and vote into the record. The vote is 13 yeses and no zero abstentions. However you should also address any sub parts of the voting question. You can also state the reason why you voted as you did if you want to. The chairperson will go down the list and each voting member will state their name and their vote into the record. I will read the vote totals into the record. Dr Brennan the vote results are now displayed. Productive for you, will you? Yes thank you.
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