SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Cell Therapeutics (CTIC)
CTIC 9.0900.0%Jun 26 5:00 PM EST

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: sammaster who wrote (781)1/16/2006 9:56:58 AM
From: Icebrg  Read Replies (1) of 946
 
Well, if they had been able to support their claim for non-inferiority, I think they could have filed for that. But as the trial was set up to prove something else, they evidently don't have the data to support such a claim (in the US). In Europe on the other hand, they have not yet sorted out with EMEA the type of statistical analysis that is deemed required.

IF approved for woman, the drug will most probably also be used off-label for men. They will have to prove their case first, though.

Spinelli, Link and the other board members who wanted to have Bianco sacked, evidently felt that this new approach is not viable.

Erik
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext