SPL starpharma holdings limited

Ann: Regulatory progress for VivaGel BV in the US, page-3

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    How is this not 'market sensitive' ?  

    Starpharma is currently working through the various options to obtain approval for both indications, recognising that an approval for one indication would have a positive impact on approval for the other indication. Starpharma’s focus is naturally to pursue the most expeditious and efficient path to approval. In assessing these options, Starpharma continues to liaise with the FDA and work closely with its team of expert FDA consultants, statisticians and legal advisors, including several who previously held senior management positions within the FDA. 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. Other options include generating confirmatory clinical data through an additional BV treatment trial. Should it be determined that a new clinical trial is the best strategy, Starpharma would be in a position to commence a BV treatment trial quickly. By way of background, a previous Starpharma BV treatment trial in the US was completed in less than 4 months and cost less than US$4M.
 
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