Flawed evaluation accepted [RSABE / ABEL]

posted by Mikalai  – Belarus, 2020-01-31 17:41 (1104 d 16:13 ago) – Posting: # 21122
Views: 17,970

(edited by Mikalai on 2020-01-31 18:26)

Dear Helmut,

It appears quite interesting. I again disagree with you.

Your approach is very questionable.

The sponsor risked and won. We are discussing a specific case. The decision tree may have been questionable, but the questionable part was never implemented. Now, let's imagine that regulators reject the study. But what reason? The reason would be that potentially, in another reality, the results could have been non-equivalent or TIE would be unacceptably high. Also one should take into consideration that at present there are no guidelines or other formal documents that prohibit the usage of this decision tree or require to control TIE and calculate the RR for the ref product first. The local NCA and ethics approved the study. In other words, the study should have been rejected because of an imaginary situation that never materialized in reality. But this approach can more or less be applied to any BE study. It is non-sense and not legally defendable. The only result would be money of taxpayers paid to the sponsor for delayed registration if this would take place in the developed world. Everything that may be a reason to reject studies should explicitly be stated in regulatory documents.

Best regards

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