Here it is almost 4 weeks since this announcement was made and as yet no word from management as to which way they intend to proceed. If another trial was to happen l would think the decision would be prompt and they would have moved forward by now. So to me it appears another course is to be taken especially given the statement l have pasted below from the May 23 announcement.
" Along with our expert advisors we, continue to believe in the strength of the extensive data package for VivaGel® BV which has supported multiple approvals around the world,"
So is it to be a legal challenge (l say no) or is it through continued dialogue and lobbying trying to convince the boffins at the FDA that their conclusions are questionable as indicated below (also taken from the May 23 announcement).
"As part of this process Starpharma is seeking expert regulatory/legal advice on the avenues available for review of some of the conclusions reached by FDA."
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- Ann: Regulatory progress for VivaGel BV in the US
Here it is almost 4 weeks since this announcement was made and...
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