Post by babaoriley on Mar 28, 2014 21:24:19 GMT -5
The following is a comment regarding the FDA brief from a friend who is only passingly familiar with MNKD, but is a very sharp fellow when it comes to biotech:
"However, on quick perusal table 5 on p. 195 of the FDA brief gives me pause. This is theoretically a good breakout as 15% is likely to be clinically significant. The TI group fared much worse than comparator. A ?5% incremental chance of having 15% of your lung function go poof would be a real attention getter. It was not clear whether this would be reversible were TI stopped or with asthma medication, etc. However, the data in table 5 was a little squirrely to my mind in that the breakout depicted wasn't obvious from the company data in the preceding figure 4 which looked to have pretty tight standard error bars (i.e., no obvious outliers that crashed their FEV1 25% or whatever) so lots of folks were probably skating close to 15% (with comparators maybe 21-24 months behind on the slightly lagging parallel curve in figure 4). In addition, that the % of type II subjects with >=15% loss was actually smaller at 2 years was weird, suggesting it may be temporary (or that affected subjects dropped out before 2 years)(or maybe that the number of subjects with 15% FEV1 reduction was small enough that the statistics it depicts are BS and table 5 never should have been created in the first place). Other than that nothing jumped out at me in quick overview. My sense is that this is a typical FDA document, not ominous in terms of type or extent of inquiry. After all the science is duly presented each committee member will seize upon one or two factors to base their vote on. People try to be scientific but, unless there is something flagrant, are really gut-based. That's where allegations of fraud and deceit originate, if the science is indecisive who would know if one or two votes were bought."
I thought some of you science types might take a look and comment. Thanks.
"However, on quick perusal table 5 on p. 195 of the FDA brief gives me pause. This is theoretically a good breakout as 15% is likely to be clinically significant. The TI group fared much worse than comparator. A ?5% incremental chance of having 15% of your lung function go poof would be a real attention getter. It was not clear whether this would be reversible were TI stopped or with asthma medication, etc. However, the data in table 5 was a little squirrely to my mind in that the breakout depicted wasn't obvious from the company data in the preceding figure 4 which looked to have pretty tight standard error bars (i.e., no obvious outliers that crashed their FEV1 25% or whatever) so lots of folks were probably skating close to 15% (with comparators maybe 21-24 months behind on the slightly lagging parallel curve in figure 4). In addition, that the % of type II subjects with >=15% loss was actually smaller at 2 years was weird, suggesting it may be temporary (or that affected subjects dropped out before 2 years)(or maybe that the number of subjects with 15% FEV1 reduction was small enough that the statistics it depicts are BS and table 5 never should have been created in the first place). Other than that nothing jumped out at me in quick overview. My sense is that this is a typical FDA document, not ominous in terms of type or extent of inquiry. After all the science is duly presented each committee member will seize upon one or two factors to base their vote on. People try to be scientific but, unless there is something flagrant, are really gut-based. That's where allegations of fraud and deceit originate, if the science is indecisive who would know if one or two votes were bought."
I thought some of you science types might take a look and comment. Thanks.
