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Stock impact report

Forbe's Herper says Ad Comm thumbs up on Puma's neratinib not a sure thing; shares ahead 36% [Seeking Alpha]

Puma Biotechnology Inc (PBYI) 
Last puma biotechnology inc earnings: 2/20 04:07 pm Check Earnings Report
US:NYSE Investor Relations: pumabiotechnology.com/ir.html
Company Research Source: Seeking Alpha
Puma Biotechnology ( PBYI ) has been up big all day on more than a 10x surge in volume as investors like what they see in the briefing documents ahead of Wednesday's advisory committee review of neratinib for the treatment of HER2+ breast cancer. Forbe's Matthew Herper agrees that the docs "don't look as bad as bears expected" but a positive vote is not a slam dunk. There are two significant "deal-killers" that the committee will address: the high rate of diarrhea and the number of changes made to the study that affected the statistical validity of the data. Apparently, the results were so concerning that the agency advised the company not to file a new NDA when it approached the regulator about doing so. Mr. Herper says the opinion of statistical expert Ralph D'Agostino will be a major factor. Provision Policy analyst Michael McCaughen says the odds of the committee backing approval are a "coin flip." Source: The Fly Previously: Briefing docs out for Ad Comm review Show less Read more
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