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Re: biosectinvestor post# 389286

Wednesday, 07/14/2021 1:45:00 PM

Wednesday, July 14, 2021 1:45:00 PM

Post# of 822112
Biogens aducanumab trial is a good example of, IMO and many others, ad hoc rephrasing trial endpoints aka the trial question. First, the trial question was (more or less) if aducanumab is improving the lives of the whole patient cohort (I think around 1500 patients). Then when the data was unblinded and analyzed they did not find any improvement in the lives of the cohort and dismissed the trial as failed. But then the Biogen department of statisticians by a miracle found that a small patient group with a certain type of genes are benefiting from aducanumab so now the question was changed post hoc data to "is aducanumab efficient for patients with these types of genes?" Answer yes is a miracle hallelujah.

Im paraphrasing here.

And also by some strange coincidence Biogen did not publish any scientific publication, more and more I admire NWBO for choosing the opposite and getting a publication done.

Im 90% convinced that aducanumab will NOT be approved by the EMA ..
By the way, the somewhat corrupt way that Biogen had aducanumab approved by the FDA will not improve the cooperation between the FDA and EMA IMO.


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