RE: Phase 2 trial??10 Nov 2022 12:48
Draye,
One has to be explicit when dissecting the RNS which one should not forget that it’s a summary …
-We are not privy to the questions asked by Avion to the FDA
-A summary , can be slightly tinted but has to be factual..
The summary from the RNS should be read , keeping in mind the above, imo
In summary, the FDA response earlier this month, recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor™ in Lupus, to optimise the clinical benefit to Lupus patients and to maximise efficacy. In addition, the FDA made additional recommendations on clinical measurements, again to support Lupuzor™ through the regulatory process to approval.