MisterBlues schreef op 21 augustus 2020 14:19:
Uit te zoeken: eerdere markt autorisatie 2005?I am sure that you are aware that RLF-100 = Vasoactive Intestinal Peptide ("V.I.P.") = Aviptadil has already existing marketing authorisations in the US, entire EU, Philippines, New Zealand and several other countries.
Here page 113 mentioning by the European Medicine Agency (EMA) Avaptadil for "acute lung injury":
www.ema.europa.eu/en/documents/annual...This is a very big point when it comes to authorisation for all countries where it is already permitted for any disease, because it means that 2 of the 3 elements namely the first two of: production process, safety and efficacy, have been already assessed and approved by these countries. Of course regulatory bodies will also look for the safety data of the trials such as the phase II/III of RLFTF, but they will focus on the efficacy. This will speed up enormously the regulatory and administrative things to be done, before one can actually place a drug in the market. This is also one of the reason why I bought this share, because it will be among the very first (if not the first) to bring a drug on the market that works. Cytodyn maybe first for mild and moderate (depending on the regulatory bodies), but these two companies will be ahead of all others. And even more important: their drugs work (different to remdesivir and other failures).
I heard this as well. In a study in Freiburg 2005 VIP was already tested. Do you know why VIP has not been used before. Its a bit strange that it has already existing market authorization, however not been used so far. Do you maybe know why?