Replies to post #120721 on Biotech Values

[iandy]

Peter, I found this reference to the discrepancy in the carrier vs noncarrier groups in your paper:

>A number of reasons might account for these findings: first,
greater efficacy was found in subjects who completed
the study and a greater proportion of noncarriers
were completers; second, more advanced A
pathology
in APOE 4 carriers23 may have affected the clinical
response; finally, the differences observed in
these exploratory analyses could be due to chance.<

http://www.butler.org/documents/2009_Salloway_Phase_2.pdf

There might be a correlation between carrier status/and/or progression of AD with frequency of VE,
10 of the 12 VE cases occured in carriers
and (interestingly)
11 of the 12 cases were at the 1mg dose.

58% of the carriers completed
71% of the placebo completed
77% of the noncarriers completed

[DewDiligence]

Thanks. Based on the paper you posted, I think now understand what Husseini Manji meant on JNJ’s webcast last week when he said that eliminating the assumption of linearity in a reanalysis of the phase-2 Bapi data gave the company greater confidence that the phase-3 program will succeed (#msg-63626970). As far as I can tell, this is a longwinded way of saying that the phase-2 efficacy measured at 78 weeks, specifically, was quite good even though the efficacy measured uniformly over the study period of 78 weeks (the prespecified primary analysis) was poor.

p.s. I wonder why Manji didn’t make his point in a way that was simple and understandable.