Content of yesterday's RNS.9 Nov 2022 11:35
Morning everyone, is it safe to come out now?? :+))
Upon trying to understand the implications of yesterdays announcement, pasted below, it suggests that we might not have to do anything, as the comment in the RNS says "seeks a review" or "further non-clinical data" i.e "either, or" It does however say " to approve the clinical study". So essentially it's a non product related issue. Frustrating, yes, but I would have been far more worried if there was reference to "clinical issues" being in question. Also bear in mind that 1801 is going to be administered to patients, hence the absolute need for diligence prior to commencement of in human trials. Yes a small delay but the trials will commence for sure once the regulatory hurdles are overcome. I do however agree with many posters here that maybe a larger institution is required to navigate and implement the trials. Gla. Andy. :+))
"seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority, or further support, of the non-clinical data submitted as part of the application to approve the clinical study"