Wednesday, June 18, 2008 9:37:19 AM
I was hoping to hear news in the upcoming days but delays seem to involve every biotech.
My assumptions with this release are that the DSMB has no interest on whether the drug works at all, they are not considering if any particular dose is effective.
Ie. if the largest dosing demonstrated no effects, they would not recommend additional patients.
Due to the small sample size of the study, statistical analysis of safety as well as efficasy would be better with additional patients
There is a side thought that if the highest dosage demonstrated the most efficasy, because of the dosage amount, having more patients taking that amount analyzed would be prudent.
Until someone with expert knowledge of the responsibilites of te DSMB states other wise, we can surmise that the dosages did show some effect and possibily the higher dosages demonstrated more of an effect but in either case a larger sample size would benefit the analysis of safety data.
If the dosages showed now effect, then safety wise, why ask for more patients when there is no drug effect
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