Member Info for Doc.Daneeka

Size It might be wishful thinking - as here we are still sitting on our hands - but we do know that STRIVE is not intended to just be a single disease platform - eventually it will accept other drugs for other conditions, and they will all need individual protocols. Whether the protocol we've seen for Shionogi is the one that all Covid inpatient candidates would adhere to is not know - but clearly it would be pretty stupid to offer SNG (as one example) a protocol that didn''t include the lessons learned from its own substantial inpatient trial.. The company wants a smaller, better targeted trial based on the post hoc of Sprinter - exactly as you describe. Can't think why you's be so keen to test a mass patient treatment that will never have huge gains for the most at risk rather than something our SNG's data.
Tommyd's point here is interesting and his reading of it may be correct.
" also interesting if you look at the Strive clinical trial record, the study title is very specific to Strive and Shionogi where in Activ2 the trial record was specific to Activ2 and drugs were listed under that umbrella."

gunto I'm pretty sure Org would have asked specifically about Strive - as it had already been mooted at this point.

Aether - I absolutely think we should be on STRIVE, and have exlained why many times. I do disagree with Td's assertion and insistence that Stacey's reply can only be a positive signal. What she said is odd but it can certainly be taken as a warning as much as an encouragement. - and given her professional position it's far less likely that she'd be tipping him the wink that we're on.

We've bumped our gums about it enough now anyway and will just have to see what occurs. I don't think RM thought wehad a chance at the Proactive interview but i think the company are going fr it now. Hopefully that's why our NIH rtrial liaisson was there at IDweek.
I also like that they have effectively ruled out Paxlo - which they might not have done, given its mechanism, and I'm happy that we are not on first because they needed longer to assess the deep dive data before making their minds up. And hopefully we'll get a tailor made protocol too !!

I answered that Doc83. None
Stacey will have a Synairgen asterisk next to your name Tommy, unless you've been presenting yourself as an interested onlooker all this time. She knows what you're asking about

Isn't it likely he still works for Synairgen ? If there were a positive spin to be put on it, you'd say he might be there because he knows NIH ACTIV/STRIVE better than anyone else ( as a consequence of his primary role on the A2 -P2 trial )

yes - we do need a pic please :) Untold riches will be yours I'm certain.

Mani I've expleained several times why they're looking at Protease Inhibitors. If the virus is still replicating they are testimg the hypothesis that dosing from any point before ICU will stop the replication. That's it. And they might be wrong but they're not looking for huge gains. Not the same as Mabs.

Tommyd that is a very good point. I thought this might be the case at the very outset but imagined it would be multi-protocol for different diseases (as it is more ambitious than just Covid) Maybe we need to look at STRIVE in the same way as we look at ACTIV - as the umbrella rather than contains different trialists each with their own protocol.
It's well designed and logical to go for 1500 for pill popping Shionogi - a therapy that they'd hope to provide to the masses for a marginal gain.
It wouldn't suit us at all as we know we need to be targeted.
Hopefully you're right and they'll do something different for each candidate

And the Eric Ding thread is a) nothing to do with us and b) deeply flawed. Turns out most deaths are in at risk and unvaccinated young children, but instead of calling for better targeting of Vax in paediatrics - he wants every child on the planet to be permanently masked again. Read the thread and you'll see many who refute his conclusions.

Manifesto won't be persuaded hSD. I can post a long list of really fast first patient to last patient dosed from Activ2 and the NIH trials. Bamlan went through both P2 and P3 in 4 months and was EUAd a month later. Even SNG - with reduced stock at outset did it in 6 months. Compare these to our own P3 which took cost £35 million.
Things take time when you dick around planning the wrong next step instead of just cracking on and proving your data, as we did from the end of our P2 ( an amazingly fast 4 month trial to topline readout) to the end of our P3 final data resolution - which somehow took 2 years.
NIH - if it supports us will give us a huge ready made trialing network and if our data is good enough we'll be authorised quickly.
I'd prefer a different trial protocol, but how much of a £50m company would a big pharma want to conduct a £25 million trial. You'd say at least 50% - probably more

Yes Doc83 I've said many times SNG's credentials are impeccable and we're the only candidate that works in both areas.. STRIVE's protocol is the only issue really. It has not been designed for us. It favours cheap mass distribution - even in hospitalised patients over the kind of specific at risk targeting that would properly test what we discovered from Sprinter's post-hoc. Ideally we'd have a trial for the most vulnerable on admission to hospital. And 500 patients less

You've missed of SAB-185 and BMS Doc 8and none of them qare eligible for Strive. They're all monoclonals except Camostat which was halted for futility. Mabs don't work in later stages of the disease and are easily deleted by variant changes. Some of them - Bamlan and Brii for eg started life in Activ 3 and only arrived on Activ-2 after they were chucked off. Bamlan was EUAd and then delteted by Alpha. Shionogi is an Activ 2b drug and still a contender as it's a Protease inhibitor which shouldn't be disarmed by further mutatons in the spike protein. Just as Paxlovid - also a PI has been selected for LC

Mani there is no other trial or JV that would further the interests of Synairgen more than STRIVE. Nothing - nowhere - for anything - with anyone. I've said this many times and you always take a different view - which makes for interesting discussion and the world go around. I was dismayed by RM's most recent Proactive interview in which he talked about the company resuming what it was doing before Covid and didn't mention Sprinter at all. That was depressing and I can't - without looking back through the RNSs - remember exactly when I thought the mood changed and they realised that Covid and/or Long Covid was still the game - but it did and they have.
RM thought we'd get a Covid trial at the AGM and then a few weeks later changed his mind and then a few weeks after that changed his mind again. Maybe it was the viral clearance data from COPD. Maybe they had the nod. Either way - until this rather worrying email from Stacey I thought we were a shoo in for Strive - but now I'm not so sure.
We should be of course and if we were it would very obviously be the best route forward.

gunto - intrigued by your " Fortunately, I don’t have to visit here too much longer. "
is it top secret or can you share your good fortune ? It can't have anything to do with the sp or the immediate prospects. Have you been left the estate of a Nigerian prince ?

Well she's saying - at face value at least, that we might not get on because our trial with them was in the outpatient setting and STRIVE is for inpatient drugs. I mean that's the literal interpretation of her comment.

I prefer your interpretation though - and the support from HSD and Wigster in particular, so I'll accept she's being more subtle than I imagined and instead of nudging you to divest yourself is encouraging a further sofa rummage. STRIVE has already shown itself prepared to proceed on non NIH data - as Shionogi's NIH trial has not completed and the good data they have is from their asian trial - so our Sprinter data is clearly of value and will be considered in any application.

I hope you're right with that interpretation, but superficially at least it looks like she's telling you not to get your hopes up. It's a really odd thing for her to say anyway given that the only candidate so far -Shionogi - has only been trialed for outpatients, in Asia and on NIH's Activ 2b - which hasn't reported yet.

Fruits I didn't think you were on the party list - but to suggest that an invite was conditional on number of shares owned is ridiculous. You just said "Add me to the list please Axe..." and that was it. It was all harmless fun at a time when we routinely had threads saying the sp would be £25 or £50 in a couple of months and we were about to become the next Moderna. Those were much more dangerous in retrospect.

the party jibes are unreasonble, whatever you may think of Axe's demeanour currently. We ALL signed up for it. It was a silly and fun idea, and the list ran to 100s. If you didn't add your name you can criticise but if you said yes and requested a booth and 2 bottles of the '98 Bolly- you should perhaps take another tack with the insults.

Mani they had our results months before releasing them - they gave SAB theirs in 5 months. They were holding SNG to await Sprinter and then the DD - and to see what happened with Omicron

We often worry about the implications for Federal drug funding if the Republicans win on Thursday, but there's another terrifying possibility explored in this Washington Post piece. "Not another penny..."

https://email.bt.com/mail/index-rui.jsp?v=2.27.1#app/mail

And again - politely - I'd question your concern about the Strive timeframe. Trial protocols always set far distant timescales.
Shionogi will have dosing wrapped up in 9 months or less. 1500 is a very big number - but they're tabs. And everyone who arrives in hospitals with symtoms of respiratory infection will get them. They'll have one of those bubblegum ball dispensers on evey ward - turn the handle and your pill pops out.

Do we have a protocol for Recover ? Can't remember if it's out or if we're waiting. That may determine whether the risk/reward for a big pharma is there. Remembering that we're not talking about the millions of people who already have LC - but only newish cases where the virus is still present. We can't do anything for exisiting sufferers most of whom got their infections and bad consequencess from Alpha and Delta.