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Message: BETonMACE and Aminotransferases

"Are you saying that for the phase 2 trial, 38% of the dosed 208 subjects had to be screened because of elevated levels of transaminase? And 5% of those 38% eventually had to be taken off of 208?"

No. During BETonMACE patient screening to enter the trial, 38% of screened patients failed to meet the BETonMACE patient criteria. Of this 38%, 5% was due to abnormal liver enzymes or bilirubin at screening. So sounds like they screened about 3911 patients to end up with the 2425 BETonMACE patients (62% of 3911).

"And if that is the case, what Patient numbers do you predict that would translate to for the current phase 3 trial and how would that effect RRR?"

This is not relevant to the patient screening.

"Also, does this information not contradict the overwhelming post referring to 208 as having “no safety issues”?"

No contradiction. The mostly modest and transient liver enzyme elevation was already a known and expected safety issue. The DSMB is likely concerned with new and unexpected safety issues.

BearDownAZ

 

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