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DewDiligence

04/19/18 9:22 AM

#218596 RE: mcbio #218589

ASBM—…part of the reason for the flattish curve [in e-antigen- patients] is due to the one patient that had the CpAM-resistant mutation and then the other two were thought to have the possible compliance issues.

Merely having an explanation for the observed (flattish) dose-response curve in the e-antigen- subgroup of the phase-1 trial does not answer the question of which dose ASMB should carry into phase-2 for these patients. That’s why I speculated that lack of confidence on dosing might be the real reason the planned phase-2a is restricted to e-antigen+.

From a business standpoint, it may be more sensible to move quickly into phase-2 for the e-antigen+ subgroup rather than holding up phase-2 to get more data on the proper dosing for e-antigen-.
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DewDiligence

06/20/18 3:09 PM

#219702 RE: mcbio #218589

ASMB R&D Day: Scientific rationale for being able to eradicate HBV cccDNA with company’s core inhibitors is based on retrospective half-life analysis of decade-old patient samples.

Caveat emptor.