TSXV:TRL.H - Post by User
Comment by
LTOWNERon Feb 08, 2014 10:44am
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Post# 22187242
RE:RE:Be brave
RE:RE:Be braveI think by 'be brave' knoll really means be patient and mature. But it does take nerves of steel to invest in speculative biotechs and by all means - keep informed! Follow closely and question everything.
In the trial PharmaZ sited Wednesday, which I just got around to reading, they took a group of frail, barely active men and gave them higher doses of testosterone than are normally prescribed! What were they thinking? Not surprisingly the highest rate of CV-related events was in the group with the highest testosterone levels >1000ng. I am thinking there are very few drugs on the market that would fare well when tested in a group of similar composition: This consisted of men with an average age of 74, who had substantial limitations in mobility and a high prevalence of hypertension, obesity, diabetes, hyperlipidemia and pre-existing heart disease. Further, a greater proportion of men in the testosterone group vs. the placebo group had a diagnosis of hyperlipidemia or were taking statins.
“The testosterone doses in this trial may have been higher than those that are typically used in clinical practice and were higher than the doses used in some previous trials … the average testosterone concentrations during the intervention were in the middle of the normal range for young men.”
The researchers admit the sample was small and the number of adverse events was small. “The results of individual small trials may not be confirmed in large trials, and trials that have been stopped early tend to overestimate treatment differences …the lack of a consistent pattern in these events and the small number of overall events suggest the possibility that the differences detected between the two trial groups may have been due to chance alone … it is essential to recognize the role that chance may have played in the outcomes we observed.”
Independent clinical trials often would not stand up to the scrutiny of an FDA submission and can have an agenda - if only to get research funds and get published.