Hi Vendor, good questions. I gather from a very quick sniff...

Hi Vendor, good questions.

I gather from a very quick sniff around some of the literature (much of which was a bit old) that UAE and a few other States do not seem to adhere solely to the stringent scientific basis of pre-clearance employed in the West.

I guess the fact their Health department is the regulatory authority allows them the advantage of effective real-time monitoring of the impact of what PRR is doing, which really amounts to a 'trial' of sorts, even though it involves commercial production and sales.

The fact that no placebos would be used if people (or more likely the Government - some ME countries have universal free health care) pay for the treatment may be seen as a humane way to proceed to test what is proven to be a safe treatment in such a disease, lacking alternatives and with some evidence of working in a small test population in early trials.

There is cerainly some appeal on a human level, rather than a strict scientific basis, to allow all sufferers to have early access, rather than the chance of placebo when the treatment is at least safe and in the absence of proven alternatives.

I would expect regulatory requirements to include the sort of manufacturing quality tests which are required by FDA et al, but they seem to be effectively allowing the 'trial' to occur in the market, perhaps confident through experience that they will be well-placed to make a thorough assesment during the period treatment is allowed.

At the same time, I imagine that allowing such sales to be made, if they felt it was not proving efficacious, then the same Health Dept could also simply just decree at any time that the treatment could no longer be offered - without the sort of process that commercially 'cleared' products in the West would have to go through first to stop their ongoing sale.

It is a bit foreign to how we proceed to unfettered commercialisation, but I expect it may be a way of doing things that they are experienced in and culturally comfortable with.

Perhaps the practice might be best understood as analagous to orphan status fast-tracking?

There is an un-met need for treatment of a disease with a high mortality and UAE and others in the region being highly developed Nations, they will probably also have a fairly high rate of ovarian cancer reported.

For PRR's part, they will no doubt be keen to carefully track outcomes for the purposes of continuing to meet whatever expectations UAE has of them and for purposes of their own.

All just idle surmising on my part, prompted by your relevant questions.

No idea as to price etc., but UAE is not short of a quid, so probably are not going to squeeze PRR pips till they squeak.

Personally, not expecting a great surge of revenue from it, but any revenue from CVAC would be very welcome on the books, and the reporting of positive results would be great.

Whatever the outcome, PRR must have put a very convincing case to someone influential to be able to go ahead and do this quite unexpected thing.

cheers