Vince Ippolito discusses everything about the Phase 2 trial for 20 minutes HERE (I copied it from the 'Well worth a listen!' thread). He is unable to offer anything substantial regarding the USA 'vehicle' anomaly, putting it down to the first time nature of producing a suitable Permetrex vehicle for the US trial (compared to the experienced Australian trial set-up). My opinion only, but he does not seem too concerned that it will affect FDA approval for Phase 3, stating that their US processes are now vastly improved from where they were at the beginning of the trial. It certainly increased my confidence as a holder.
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- Ann: BTX 1503 Acne Phase 2 Study Results Presentation
Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-372
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