Count Dr. Charles "Snuffy" Myers as one of the latest cancer specialists who faults a cruddy trial design by Dendreon as the primary reason for the FDA delay in approval of vaccine treatment Provenge.
His comments are available at PharmaLive.com. Here's an excerpt.
"Dendreon made major and obvious mistakes in developing Provenge. The FDA is not some sort of bad guy -- at least in this case and yet Dendreon's stock continues to rise," Myers' says. "The primary end point of a clinical trial seeking FDA approval should be either survival or improved quality of life, but Dendreon still chose to muddy the waters by changing endpoints midway through the clinical trial, forcing the FDA's hand with their poor design."
"This is actually the second time that we've had a useful drug fail in development. The other was Atrasentan (a.k.a. Xinlay)," Myers adds. "Again, it failed not because of the FDA but because of drug company incompetence. While the FDA is far from perfect, people need to understand who to blame in this case."
Myers, a prostate cancer survivor, writes for the newsletter ProstateForum.com.
Pupule Paul is long DNDN.
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