Synairgen Share Discussion Threads

[trinitygooner] 31/7/2020 12:53

Would PHE allow a small scale approval for certain cases?

[nobbygnome] 31/7/2020 12:38

We won't get a collective statement from regulators as they don't act together but in isolation. The most likely to hear from first is the MHRA but I wouldn't guarantee it. I wouldn't be surprised if the FDA trump (no pun intended) them just because they seem to be more on the ball at the moment!

[elsol] 31/7/2020 12:32

I do not think a formal phase 3 trial will be needed. Just a conditional approval with careful monitoring and reporting by clinicians. The SNG product was used recently in a home trial then there is already some good background evidence to suggest this is the case. Such is the human need and this treatment is very safe as shown by many global scientific papers over many years. I don't think its long until some sort of collective statement by regulators in this regard. I'm guessing sometime during the next 10 to 14 days we are supplying product to the masses. The only limit is how quickly we can supply the neb. kit and drug formulation.