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) -- Ignore unavailable to you. Want to Upgrade?


To: Sam Citron who wrote (531)3/7/2005 2:01:20 PM
From: Icebrg  Read Replies (2) | Respond to of 946
 
No, there will be no need and there is no money for new trials. CTIC's strategy now appears to be two-pronged.

1. Try to convince the FDA to amend the SPA for Stellar 2 (?) to allow for a non-inferiority primary endpoint.

2. File for a non-inferiority label based on the results from Stellar 3 and/or 4.

There is of course still a possibility that Stellar 2 and/or 4 meets its original endpoint. It is however impossible to have an opinion on how likely this is, as long as we have no idea if there was a trend or not towards superiority seen in Stellar 3.

Erik



To: Sam Citron who wrote (531)3/7/2005 2:20:06 PM
From: scaram(o)uche  Respond to of 946
 
Sam:

I had a small bet on the company because I wanted a jet like the CEO's. That's about it re. independent CTIC analysis, my camp..... shopping for my jet.

I consider the analysis and "bent" available in this thread to be excellent, and had diversified accordingly.

Best,

Rick