Member Info for ChrisToffer

P.s He mentioned in the webinar that they would be starting P3 in the UK first, "in the coming weeks". They don't need an IND to start the trial in the UK as that is an FDA process that allows them to move the drug across state lines.

The IND is a strange one because i've seen a few companies RNS the application but it doesn't feel like SNG's way. If they submitted it ASAP, like within a week or so of the 14th October RNS then we should be clear of the 30 day grace period any day now.

Interestingly, the NIHR P2 trial status is closed https://www.nihr.ac.uk/covid-studies/study-detail.htm?entryId=281317 and it has the hometrial link at the bottom??

The EU P3 register says 'recruiting' (it always has) but the one to watch start to watch out for is here https://www.nihr.ac.uk/covid-studies/study-detail.htm?entryId=290965

It is still a bit of a mystery why they updated the US register to a P2/P3 Pivotal trial way back in August. They need the IND to even start trials in the US but with Professor Holgate mentioning US home trials it does feel like there is more than meets the eye with the FDA approach.

That link is for SG016 which is not completed because the home arm is still recruiting. It was last updated on 27th August, long before they decided on a P3 or its numbers. The EU clinical trials site has a whole new page for SG018 (the P3).

That's the P2 Dibs, however there is still a bit of a mystery around the changes made on 27th August to update it to a pivotal phase 2 trial. I wonder if we'll see a new page on that website or if that one will get updated.

They could definitely help in that regard Enrico. Government orders (subject to approval) would be a huge boost to the short term SP as well as publicity.

I'm not so sure wetdream. There's no one on TV plugging any trials. The most we get is Whitty saying how grateful they are to people who come forward.

Thanks for the update Vorag! Good to hear!

Budesonide is a licenced drug so they can advertise for that trial, whereas Synairgen cannot. However RM said in the webinar that they are working closely with the Principle trial on recruitment with SNG's home trial. He said that where appropriate, they would pass patients in either direction.

Maybe the advertisement of the Principle trial is not such a bad thing?

DP, the home trial focuses on test subjects very very early. Since you feel that P2 was a wasted opportunity and that Synairgen should re-think their approach to P3, have you thought about applying for a job there?

That does make sense. UK government may have already been told to keep their hands off. It was interesting in the webinar when RM said that they would want larger compensation for the Covid work in any deal that's made in the short-term.

Good to have you back SS :D

Tattyhead, they can't do that! They cannot market an unlicenced drug.

RM mentioned the principle trial in the webinar and said that they were working with them and would at times pass more suitable patients back and forth.

Hi SYN, a lot of other companies appear to shout it from the rooftops when they submit an IND however I wouldn't be surprised if SNG have submitted it and not RNS'd. They said on the 14th Oct they would submit ASAP

Spinnaker/Sarah, Parexel are running the P3 trial. See 14th October RNS

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

It's 30 Calendar days however we are making the assumption that they made the application at some point in the week after 14th October RNS. I thought the following Monday was a fair assumption as that gave them 5 days and, crucially, a weekend to finish the application. It may have taken longer to apply but i agree with you that it must be close!

Hi Blessed, it's 30 calendar days from submission so if they submitted on monday 19th it would have elapsed last wed. I was thinking along the same lines. It still means we could see the IND grace period clear any day.

It's about scope; the more countries approved under the trials the easier it is to fill it. As RM said, they have to chase the virus around the world. It doesn't mean it has to be an even split across countries/sites however the benefit of having the trial established in many countries is less regulatory barriers to break through when the approval does land.