News: SPL Starpharma Holdings Says VivaGel Condom Receives Final Regulatory Approval In Japan, page-16

Let's just get to the elusive $2 first before we worry about $4 IMO

I'm not entirely convinced we have been told all that SPL know re: FDA request .... I posted last week that the FDA (IMO) is not going to issue an ambiguous notice in this process - they would have had specific requests ..... if so, I want to know what these are ?

..... SPL have of course covered themselves by both the ambiguity of the content in last weeks announcement and also this statement 'confirmatory clinical efficacy data' - no one knows yet if this does mean an additional trial will be required but if it does mean another trial is needed, SPL will be able to say "we told you that in 27th December, 2018 announcement - confirmatory clinical efficacy data means a further trial is required" .....

..... if management didn't have a track record of making ambiguous announcements for the last 14 months in relation to Vivagel Launches that didn't eventuate, I would give them the benefit of the doubt in this instance, however sadly we all know that not to be the case.

DEP is certainly the main game here IMO, however I cannot help but think we are in for a world of hurt when all the facts pertaining to the FDA requirements to enable approval of Vivagel BV are known ... especially if it affects or dissolves the USA Licence deal with ITF Pharma ... I so hope I am wrong !!