Member Info for ChrisToffer

Thanks Dibs, there is a possibility that the goalposts have been moved again causing further delay, however this delay may be for the benefit of all. The goalposts being moved to reduce the trial numbers by a third was very welcome.

ZK, the RNS on the 18th December said 'Phase III trial to commence dosing in UK imminently'. So that kinda supersedes anything that was said before. And the next one that confirms first dosing will supersede the one on the 18th.

It's very straight forward folks, it hasn't started.

Its been asked of the company and the answer was yes. It's material news therefore it has to be RNS'd.

Hi Ghia, with Foralumab targeting moderate-to-severe patients they may be more suited to Activ 3 rather than an outpatient trial?

https://www.proactiveinvestors.co.uk/companies/news/937560/tiziana-life-sciences-completes-clinical-trial-of-nasally-administered-monoclonal-antibody-foralumab-in-covid-19-patients-937560.html

i'm sure someone would balls it up but at that point we won't mind so much because it'll be out there

https://www.youtube.com/watch?v=EzuHmVhNbBY

Forgot the link

Hi Faye, the new nebuliser (the Aerogen) is designed to allow the drug to be self administered at home. The Nebuliser arrives with 28 glass filled syringes and the patient would inject 2 of the syringes into the nebuliser and inhale. This would be repeated for 14 days. Here's a video of the aerogen set up guide. very easy for home use.

Its a different nebuliser (philips i-neb) for the current UK home trial. That only needs one dose of SNG001 and any filling or inhaling is done under supervision over video call.

Trial start is material news so they will RNS. Theoretically it could start anytime between now and Sunday and we won;t see an RNS till Monday. Any day next week will do in my mind because of the reduced patient numbers.

Thanks Ghia, that's a very fair point that i hadn't considered. Because of the ongoing licencing discussions the re-rate could happen in a heartbeat!

HarChris, that's fair enough if it's been adjusted. The point still stands though, £310m/100k treatments gives a treatment price of £3100. That's a little high however its starting to get close to the price RM was quoting. Now the price may end up being a lot less, however that's only 1 month of sales! They could half the price and reach the same NCYT annual revenue in 2 months.

NCYT is an interesting one as it led the way in 2020 for AIM stocks in the fight against covid. We should remember though that their half year report in Sep suggested their 2020 full year revenues would be c.150 million euro. They currently have a 580m market cap.

If SNG001 gets approved, even the most conservative pricing estimates on 100k treatments a month will multiples of that kind of revenue.

The RNS said the aim was to start in Q4 and TW said they hoped to start dosing this year. However that was before they cut the trial numbers by a third. The discussions that led to the trial adjustments may have a knock on effect on trial start however they will ensure a much faster trial when it does get going. This week or next week, i'm relaxed because we're in good hands.

Hi matterhorn, i noticed that weeks ago and emailed consilium as well and they said they would check with their NIHR contact to get it fixed. Unbelievable!

HarChris, that depend on how much the market values a treatment that helps in the fight against covid. Treatments will still be required in 2021 and beyond. There are currently no treatments suitable for home use.

£4 a shares values the drug/company at 800m. It is not a binary bet in my mind because the possibility of the drugs use in other application however if it even shows moderate benefit in covid patients, enough to get approval, then its gonna be worth a lot more than 800m.

Thanks Dan and all the best out there!

Prosecco, i believe Amers is referring to the MAP, which has to be facilitated by your GP.

DanRey, do you know of any other reasons (apart from paperwork) that a GP may not even consider the MAP?

Hi Amers, that's awful! Hope ya feel better soon!

Home trial; www.covidtrialathome.com

MAP; Healthcare professionals in the EU can obtain details about the SNG001 Managed Access Program by calling the customer service team at +44(0)1283494340 or emailing medicineaccess@clinigengroup.com.

My initial thought to the addition of 'time to hospital discharge' was that it likely came from the FDA due to the current state of their hospitals. Also as a comparative marker to other FDA emergency approved drugs, namely Remdesivir which got approved after demonstrating a benefit in time to discharge (and not much else).

In any case, i see an additional endpoint as a positive.

Phonejacker character!

https://www.youtube.com/watch?v=SRILKrkqYnc