Member Info for Doc.Daneeka

Looking forward to the day when you have nothing left to say Mani

Morning Fruits - Been a while since anyone said "they want your shares" on here. Sure that gave many a good laugh.
The idea that anyone would pay people to deramp the stock at the moment is derisory. It isn't so fanciful to imagine traders trying to ramp it from here but the price is where it is and will stay here - within a few percentage points - until the next piece of major news.
Andyb will post his occasional bits of devilry and MrC will gladly chip in, but you musn't confuse that with those of us who want a serious discussion about where we are and what might be coming down the line.

Your post was an oasis of good sense and balance Palladin. Plenty of us on here are still committed (and have no alternative but to be so) but will not allow the board to be swamped with inane rampy nonsense.
Anyone who posts regularly about timelines without ever looking at the kind of trial that most likely awaits SNG is either stupid or deliberately ignoring the reality of the international trialing space that remains for Covid. Anyone who suggests that the long awaited LC or long absent A2 data are fast routes to EUA is equally delusional.
If Ghia's post from Org is correct (and i'm sure that it is) then our immediate material timeline slips again from August to September/October (as NIH will not necessarily announce immediately that dosing has begun) Of course we have no idea if we'll be included on STRIVE but it is so clearly the best hope for the drug that we have become fixated on it. We all understand that if the stars align and SNG is one of the first candidates: the drug, the compnay and our investments should have a solid future.
Several posters have long held and deep animosity for the poster who has so many names - but in this instance it's clearly true that Org has been in regular contact with Stacey Adam and she has let slip important little nuggets of information.
These little snippets are clearly more important to our future than endless postings of the general potential for interferons.
So I say - thanks to you and all the others who keep a balanced view - and thanks on this occasion to Org (and Ghia ) for a useful update.

i provided some examples of the kind of trial size we might expect for the LARGE platform trial the company is seeking to join. Not interested in your pettifogging rebuttals. This is just the reality of the space we’re seeking to find a place in. Hopefully they’ll decide that with dwindling overall case numbers and still a real need to find solutions for the most sick - that STRIVE should launch with smaller and better targeted trials. Recovery’s continued adherence to 8000 seems bizarre as they must know the trials will never fill unless the world goes mad again.
No intention to be controversial here but we’re all waiting for a platform trial and we should really and legitimately discuss how it might look.

my figures are all courtesy of NIH, Recovery and individual company peer reviewed data. Nothing made up about them. 1k is the minimum we can expect as a start point and one trial with lower figures only provides a counter argument if you’re delusional

Fruits it's based on a number of things - but it could be an under estimate. If we think SG018 was underpowered at 633 - and the belief that it could have succeeded with just 100 more trialists. Some drugs have been EUA'd after small trials but
Recovery requires 8000 for Paxlovid and Molnupiravir.
"Participants recruited to the RECOVERY Trial are randomly allocated to receive one or more trial treatments plus usual standard-of-care, or usual standard-of-care on its own. In the Paxlovid comparison, participants will receive two 150mg nirmatrelvir tablets and one 100mg ritonavir tablet twice daily for five days. The trial aims to recruit at least 4000 patients to each treatment arm, to be compared with at least 4000 patients who receive usual standard-of-care only.

Paxlovid's outpatient trial was 3000 patients and stopped at 70% after a succesful interim analysis. Molnupiravir's outpatient trial recruited 1433 and Sotrovimab's P2/3 recruited 1053 patients.
NIH's Activ 3 inpatient trial protocol specified 1000 patients for each trialist.

It might be less - but 1000 is the benchmark and it's unlikely at this stage that they'll be reducing the number of trialists required.

Gunto that's not what Stacey said - she said it was hoped it would eventually be an umbrella platform. We don't have a protocol yet so we will have to wait and see. Anyway - it doesn't matter - what matters is getting onto it it now. If they somehow create a trial that will simultaneously test v flu rsv and covid and we're on it, then my hat will be in the air with everyone elses

I asked for it to be deleted. Enjoyed the break.
As i said before - if you have anything useful to contribute - be my guest. But you won't because you're still just a fangirl and you still know nothing.

It's me Mani - I took a break. If you have anything to contribute be my guest. I won't hold my breath

Gunto - Recovery is Flu as well - genuinely asking for trialists to test each simultaneously but i doubt STRIVE will be in the same way. We'll see soon enough but the multi viral v multi-viral discussion is old and didn't go anywhere the first time round.

Which platform for this drug, and how long to recruit the 1000+ patients required ?

We're all hopeful of STRIVE of course - it fits us very well in lots of ways and we know it's probably the fastest bet by a long chalk - with the continuing (relatively) high levels of Covid in the States.
The evidence linking us is all circumstantial but RM stated in the RNS that ended Activ2 that "lead investigators from ACTIV-2 and Synairgen are in ongoing discussions to try to identify an appropriate clinical trial to continue the evaluation of SNG001." (17/3/22) STRIVE is the first such platform that might be considered "appropriate", and the first new iniative from NIH since Activ2 was suspended. We'll know within the next 2 weeks if P3 and A2 data can combine to get us onto this new platform and if the dots start to join up.
If SNG gets onto it now, there's a chance we'll see results and maybe even an EUA within a year. There's also a chance it'll take a lot longer unless new variants reverse the global reductions in hospital admissions.

If the company is applying to Recovery the timescale will surely be much much longer. Free trial or not. Between late March (when it commenced) and July 25th 2022, Pfizer dosed 200 patients with Paxlovid. 200 out of the "several thousand" required for its inpatient Recovery trial. With the drug available at 177 UK hospitals. 50 patients a month from a company with limitless resources as the second Omicron wave increased numbers in hospitals. Doing the maths on this ( and setting a conservative 2000 as the number required ) Paxo should announce LPD in mid 2025.

Looking at the most recent Our World in Data slides and apart from the US you'll see mostly empty ICUs and negligible numbers of new ICU admissions everywhere. If the most poorly are not progressing to ICU then it's difficult to see where anyone's inpatient trialists come from - even in the US.
RM said ""Conducting clinical trials in the time of COVID-19 is challenging " in the same RNS. I'm sure he'd agree 6 months later that conducting a Covid 19 trial at a time of very little Covid will be even more challenging.

Everything can change really quickly of course - but without something that creates an added level of urgency - ie a new variant that evades both mabs and tabs - or a performance so stellar that the trial is halted early - SNG will most likely spend at least the next year on STRIVE - or the next however many years on another less well support platform.

My purpose here is to introduce a realistic and fact-based note of caution about the speed of the next step. And I'd like to ask what other options there are for a PT ? And can anyone point to Patients-per-month timescales for the most recent trialists on those platforms ?