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Doc logic

10/12/22 4:02 PM

#521437 RE: Umibe5690 #521169

Umibe5690,

That was my original thought too because of this issue and the influence of Dr. Ashkan on all things UK. The fact that he was the one updating where the article is in the process of publication is a good hint that it is a UK journal. I still think timing needs to be acceptable to NWBO since attacks on partial news towards approval are always expected and a journal article by itself may not get the monkey off the back of NWBO. They will need to say something more than “we hope to...”.
We are getting close enough to MIA approval with potential MAA approval right behind that any journal article hitting the air waves could be short lived news even though having long term influence. NWBO, Dr. Linda Liau and Dr. Keyoumars Ashkan need to be ready for the coming change. There is also the option for any journal waiting on FDA to wait for an approval notification as a green light after being ready so that the 2 events are nearly simultaneous. MHRA could announce first in this scenario or choose to announce with FDA if FDA gets caught up. If FDA does not catch up then at that point they would be demonstrating outside influence has caused them to become more of a has been amongst regulators even though they oversee the most lucrative market.. Not a good look. Best wishes.
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biosectinvestor

10/12/22 5:12 PM

#521454 RE: Umibe5690 #521169

I have said I from the start that if no US journal would be willing to accept some sort of language relating to the outstanding ECA guidance, and I do think that side article was an effort by FDA to maybe be broadly more affirmative of the policy than the rest of the agency, that then they would most likely go with a UK journal. I believe BMJ or The Lancet or Nature would be the most likely preferred candidates.