statistical shell games? critical questions for the company and our future
note important additional info about the BOM trial recent PR's
12/11/17- initial data release somehow the initial n gets winnowed down from 61 then 46(mITT) and then further to 39(PP). data released relates to incidence of SOM. These are pretty big cuts
1/3/18-new data out re onset of SOM
4/9/18-new subgroup analysis of SOM and timing of chemo administration- weekly dosing of cis-platinum vs higher q 3 week dosing. Some of the data look very good, some less so. Careful breakdown of the data provided yest by kmbjn, commentary by frrol, background context by slc immuno.
ponder, please:
1) key secondary outcome measure DURATION of SOM- NO DATA reported! 1/3/18 PR notes that small numbers meant they could not say there was a benefit. This is a truly awkward part of the PR, folks, just re-read. Please recall that In the Sonis hamster model studies(not just for BOM but for all the drugs he tried), and in B OM interim the duration of SOM as shown by AUC was a key bit of data(for hamster studies main data point). Clear failure to achieve anything they could report for this very basic outcome measure
2)The numbers get very small for these subgroups. So small that you end up saying that there is more SOM with B OM than with placebo for the q 1 week cis plat group. What does that tell you? It tells you THE NUMBERS ARE TOO SMALL TO BE RELIABLE.
3)We have already seen(P2a) just how misleading it is to report percentages of small trial numbers as if that represents real data. The P2a info requires a large degree of skepticism, as reported in those silly graphs that are based on so few actual patients.
4)We now get very small patient numbers purporting to be meaningful for B OM, in addition to prior P2a. People who understand epidemiology and statistics much better than I will be employed by pharma acquisition teams, and they will be acutely aware of the lack of reliability of such data.
Innov Pharm must be very careful with their numbers, and we must be mindful
