RE: Other Company14 May 2020 00:48
It is important to remember that the single most important market for sexual health products is the USA. If modelled on the revenue from erectile dysfunction drugs, this will account for 65% of global sales. The whole of the EU is likely to be 12-15%. That is why they are persevering with approval in the USA, despite many obstacles the FDA retrospectively introduced e.g. need for disease definition of PE and a validated PRO.
The Numan products should be seen in that context. The USA is the key value driver for Regent stock.
The most important factor is that there is absolutely no peer group reviewed clinical data to support the claims for their delay spray. In fact it looks like they are “borrowing” claims from the Fortacin label. That indeed was the case previously with Promescent that used our clinical data on their website until they were stopped with a “cease and desist” notice. The reason is that they don’t work or have obtrusive side effects particularly penile desensitisation.
In that context, their website would be illegal in the USA as this type of agent can be sold as a “monograph”product as a penile desensitiser and medical claims ‘’......for the treatment of......” are not allowed by FDA.