In London at Rodman and Renshaw conference Alex M. indicated that Theratope may be approved in a non-US jurisdiction with a Phase IV requirement. In today's press release, he said not USA and Not Europe. Somehow I doubt that Canada would grant approval without a further Phase III.
Did anyone participate in or listen to today's AGM? Was anything further said? Unfortunately, my high speed modem died and I've been without an internet connection all day (and probably for the next 5 days... Though they tell me the replacement will be 3 times as fast at 3MBits/second. I'm not sure that 3 times "instantaneous response" will produce a noticeable improvement other than when I'm downloading / uploading very large files.)
Ian
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extract from today's PR...
Moving on to Theratope, Dr. McPherson will discuss the status of this product candidate. Since the final analysis of the Phase III trial in 1,030 women, which did not show statistical significance in the overall patient population, Biomira has continued to analyze data from the pre-stratified subset of 350 women who received Theratope plus hormonal anti-cancer therapy.
“After a review of the current data and discussions with key opinion leaders, we believe that more information would be required to support a registration,” said Dr. McPherson. “We continue to examine the data from the Phase III trial and investigate the mechanism of action. We are looking at the possibility of conducting a new Phase III trial in the patient population that appeared to see clinical benefit. We expect a decision by the end of June on our plans for next steps with Theratope. That being said, we continue to explore the potential opportunities for earlier registration based on the current data, perhaps in jurisdictions other than the U.S. and Europe, although we anticipate a Phase III clinical trial will be required.” |
