Member Info for Peelweight

BC, it was 7 weeks and 4 days between hospital P2 last patient RNS and top line data RNS

Last patient enrolled in SPRINTER RNS 11th November. 7 weeks and 4 days after that comes out at 3rd Jan. I agree with fruits that Chrimbo/NY will slow matters down. Also bigger trial in lots of countries but we are a bigger company now to deal with that. My best guess is middle of Jan for top line data RNS. They will ideally want to be announcing they have been granted a US EUA and preorder at the same time (if P3 anywhere near replicating P2)

GLA, not long now!

BG, wink’s as good as a nod, understood!

I think this treatment will be another option for preventative treatment, especially in those who can't get a good response from vaccines, for example those with immunosuppression (circa 1m in UK). It will be too expensive to be used much further than that I reckon. It is not in the same market as SNG001, it is in the pre-infection arena. Might reduce the market size at the margins in some countries/for some groups of people (hope so for human health) but not my much IMHO

Good shout Brand, hope so

Yes this time next month (16th Dec) is day 35 and is etched on all Synners minds but only RM and crew will know that day. Rest of us early 2022

Just can’t wait!

ALWHIZZ, loving the volume of a sphere reference
- or perhaps you refer to a total balloon!?

Sorry Elsol, yes 16th December. TheboyG, I think blinding will not be broken for 35 day data until 35 days from today.

Thanks Cocoloco. Any other retail outlets/service providers that Synners should spy on?

Synairgen will have all 35-day unblinded data visible for quality control and statistical analysis on 16th November.

Do we have spies in the off-licenses of Southampton in our network?!

If our SPRINTER P3 reads out at anything close to our P2 and safety still excellent, EUA at that stage IMHO. Especially as the FDA helped with exact design. EUA is emergency use, NOT full licensing. That would be considered later with full data. Publication later too

Agreed fruits, all additional data welcome! Especially freebies like the ACTIV studies

A5404 is a phase 4, open-label study that aims to learn about the difference in neutralizing antibody (NAb) responses to mRNA-based COVID-19 vaccines among participants with prior SARS-CoV-2 infection who participated in ACTIV-2 (who either received an investigational COVID-19 treatment or placebo or active comparator) and participants who have no history of COVID-19 and did not participate in ACTIV-2. A5404 will enroll 70 participants each from five different ACTIV-2 therapy groups and up to 70 participants without prior history of COVID-19 for each ACTIV-2 therapy group.

In the first cohort, ACTIV-2 participants will either receive the Moderna COVID-19 vaccine through the study or the Moderna or Pfizer COVID-19 vaccine at a community site. They will receive their vaccine 30-240 days after their last day of ACTIV-2 study treatment.
In the second cohort, participants without history of prior COVID-19 will receive the Moderna COVID-19 vaccine through the study.
All participants will have their blood collected and their immune responses measured as close to when the vaccine is administered as feasible and at eight and 20 weeks and one and two years after the first vaccine dose.

My take on this - an interesting question that will take ages to report and not seminal to us. Basically looking at antibody response to vaccination in those who have never had COVID (up to 350 individuals), versus those who were randomised to be given placebo/comparator arm(RegenCOV) in ACTIV 2/3, versus those who had one of the investigational treatments (70 per investigational drug). These include 70 who had SNG001, one of 5 drugs looked at (3 promoted to P3, and 2 under consideration of promotion)

Also Matterhorn, thanks a million for the full trial protocol!

Matml, point taken about the p-value hurdle to be cleared. Still v positive to hear about the lack of failure to futility after 300 recruited.

Matml thanks. That really does sound encouraging to me. I think a Z-score of 1.4 (1.4 standard deviations) does represent a 42%+ movement in the desired direction with respect to the mean for those two primary endpoints you list. If I understand that correctly, it has to be very good news IMHO

Thanks Matterhorn, no rush!

Matt, thanks for bringing up the z-score of 1.4+ for futility analysis after 300 patients. I am no statistician but does that mean they were checking there was 42% (or more) of a positive deviation above the mean outcome in the placebo arm for the primary outcome. I am amazed and will be very reassured at how hard that was to pass after the 300th patient to avoid futility stopping the trial. Big caveat here - I AM NO STATISTICIAN!

Good luck with that Putagucci. Phone was addictive prior to SNG, now surgically attached to many a palm!

That’s the spirit Elsol!

I’m no expert but low volume and this price indicates running out of sellers. Surely a good sign