...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: National Kidney Foundation -Abstract: BOM

"Hint that maybe a new study is necessary for NDA in the NR this morning "

I think its more than a hint: (from today's release)

“The results published in JAMA bode well for the future development of apabetalone,” said Professor Kausik Ray, Professor of Public Heath, Imperial College London, and the lead author of the study. “We have learned a great deal from the data generated in BETonMACE, which is being applied to the design of Resverlogix’s next study to address an unmet need in a high-risk patient population.”

 

from the top of page 8 in the most recent MD&A:

... "In the case of apabetalone, BTD will potentially allow for an interim efficacy analysis in a subsequent clinical trial to support regulatory approval thus shortening the overall development time."

CEO has mentioned several times on webcasts the possibility of more trials, and the possibility that those trials could be shorter ...the BTD would seem to support that.

I know many shareholders are looking for an outright sale, and may not have the patience for more clinical trials.  I get that.  However, a well designed trial with a successful interim efficacy analysis would (in my humble opinion) provide a larger pay-off in the end.

Share
New Message
Please login to post a reply