I have no doubt..........it is the situation with FDA and NDA of BV Gel saga in the USA that is holding back share price of company
What lead up to this is purely speculative
In late December of 2018 we received what was suppose to be a slam dunk decision by FDA to approve product with a knock back. The CRL shocked not only all share holders but management of Starpharma as well
Just days before first attempt - a deal worth US$101 (AU$157.81) million + plus tiered royalties was signed with ITF Pharma to sell the product into the USA
On approval of product for both indications an upfront milestone payment of US$20 million (AU$31 million) would have gone into the Starpharma coffers
16.5 months later it has not been made clear by Starpharma why we havn't initiated a treatment trial in the US
What is clear......we have all these experts talking with FDA, and yet nothing visibly concrete has emerged from the bunkers
My thoughts are.......eventually the product will be approved (either OTC or prescription)
In the meantime we wait and we wait and we wait
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