RE: Who Solidatory Results17 Oct 2020 00:43
I believe some hard questions need to be asked of Faron let alone the WHO re this trial. One assumes Faron made it clear to the WHO when invited to enter the trial that T should not be administered to patients on steroids- they should have got some kind of written statement. Also was anybody genotyped for the SNP profile which responders are thought to have ? Faron knew very well this was not the case as the trial progressed and that the usage of T was minimal. In that case from a scientific viewpoint and possibly an effical one as well Faron should have withdrawn from the trial and made it clear publicly why. Commercially it made sense to stay in , for marketing reasons ( raising awareness of the company etc ) but Faron privately knew what the end result would be months ago and made sure they had the damage limitation RNS ready to go when the news broke. I question I would like to ask - but I won't get an answer-is how is T being administered in the REMAP trial- ie with or with steroids ? I guess Faron had to accept the invite from WHO but it smacks of time wasting. The only acceptable evidence - as Faron know- re the value of T, is a successful phase 3 - HIBISCUS, Right now we are not much further ahead in this respect than 2 years ago, all we have is a design plus a site, but no FDA approval of the trial yet and no money to run it, despite Faron telling us a partner will foot the bill. Even if the funding comes in soon- $ 20 m needed, which is a BIG ask , then its at least 2 years before results will be published which may result in a license. My belief is that FARN regard T as a Bluebird, if it comes in great but if not they are not losing any sleep over it-, they are putting little if any of their own funds into it. I have been in Faron a long time and have respect for them but patience does get tried at times. What we need now is good solid clinical data to show Clevegen is actually effective in the various cohorts. We have good biomarker and Tox data but the last patient results are from way back. Lets hope we get some soon and get the SP up....