Replies to post #161092 on Biotech Values

[DewDiligence]

KYTH—…there could be some safety imbalance from…DMC that the company felt it would be better to have all safety data collected under blinded condition.

If management received a safety update from the DSMB, it would have been in blinded form; hence, what may be troubling to management is not a reported safety imbalance between the trial arms, but rather an inferred safety imbalance predicated on a higher than expected rate of AEs in the (aggregated) blinded data.

Given Bayer’s success with the ex-US phase-3 trials of ATX-101 (#msg-84146742), I previously considered KYTH’s North American phase-3 trials to be relatively low-risk. I no longer think that.

All told, my antennae are telling me that ATX-101 has some kind of safety problem and the protocol change is not just a technical tweak to comply with PDUFA-V, as the company claims.

An additional wrinkle disclosed on today’s CC is that Bayer is holding off on submitting an MAA until seeing the full safety dataset from the North American trials!