Biotech Values

[DewDiligence]

ANDS is evidently playing games by reporting non-ITT data in the calculation of EVR in the phase-2a ANA598 trial (#msg-50475044). Below are the EVR data as reported in ANDS’ PR last Friday. (ANDS defined EVR as VL <15 IU/ml after 12 weeks of dosing with ANA598 +SoC.)

                           
 Arm                            EVR 
 ANA598 400mg BID +SoC (n=34)   75%  
 ANA598 200mg BID +Soc (n=29)   73% 
 SoC control arm (n=32)         63%

What’s the problem? Well, there is no numerator that can be paired with the denominator of 34 in the 400mg arm to produce a quotient of 75%. (25/34 rounds to 74%, and 26/34 rounds to 76%). Hence, the denominator ANDS used to generate the 75% EVR rate could not have been the ITT denominator of 34 patients.

Similarly, there is no numerator that can be paired with the denominator of 29 in the 200mg arm to produce a quotient of 73%. (21/29 rounds to 72%, and 22/29 rounds to 76%.) Hence, the denominator ANDS used to generate the 73% EVR rate could not have been the ITT denominator of 29 patients.

I previously noted that ANDS was being disingenuous with its data reporting in this trial (#msg-47096721). It appears that they are doing it again.