Vanaf morgen 16 April is het pas echt "game on" richting het FDA besluit. Ter "aanmoediging" wil ik een ieder onderstaande reactie nog meegeven van CEO Leon Van Rompay tijdens de conference call met analisten op 9 Maart jl. op een vraag van Thomas Vranken namens KBC Securities NV.
Dit was aldus een dag na het positieve Canadese besluit omtrent Estelle op 8 Maart jl.:
Thomas Vranken, KBC Securities NV, Research Division - Equity Analyst of Pharma & Biotech [7] -------------------------------------------------------------------------------- Fantastic. Yes. I have 2 questions from my side. The first one is could you shed some light on potential time lines for Donesta partnership? Will this be subsequent to a final readout in Phase III? Or could we rather expect an announcement on this aspect sooner? And then secondly, maybe is more on Estelle manufacturing. I was wondering to which extent will manufacturing of Estelle be taken care of by Mithra CDMO as compared to potential outsourcing to third-party manufacturers? -------------------------------------------------------------------------------- Leon Van Rompay, Mithra Pharmaceuticals SA - CEO [8] -------------------------------------------------------------------------------- I can do the first, if you want. This is Leon, the CEO. I will tell you concerning the Donesta licensing, the longer we wait, the more we create value. It's our belief that as we show now with Estelle that we can do the registration, that we can persuade the authorities to give us a registration worldwide because we are quite sure that Europe will follow and also the FDA. So for the same compound, the same, let's say, active ingredient, will be Donesta. I think that we are quite sure and optimistic to receive one day the registration. So the longer we will wait for a deal, the higher the price will be. So I think it's -- and we don't have any, let's say, cash -- our cash position is fantastic. So I don't see why we shouldn't wait to increase the value of Donesta. The [shorter] our launch, we believe, the higher the price. --------------------------------------------------------------------------------