Add onto this the latest application to FDA of which we have no details of- is it data, lawyers , re submission or just a hail Mary to extend out fact it is still onfoot?
A new CEO would usually want full control of such - instead we have JV and consultants having done it before end of DEC-. Why the timing - was it that it was a deadline set by FDA for last possible response time - was it a SPL internal must happen by JF? Was it JF doing her last hail mary and guaranteeing a retention process for 6 months consulting knowing that it should be wrapped up inside 12 months?
I think that the new CEO should answer to shareholders in regard to the timing of latest information to FDA and actually set out what has been lodged. IMO should also set out any timeline going forward assuming their data/ application is accepted for review and if there is a further pathway should it be simply rejected.
New CEO needs to set out if current application the cost and timing of a suitable trial going forward or drop it or partner it .
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- VivaGel trial results, failure history and FDA appeal
VivaGel trial results, failure history and FDA appeal, page-3
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