Member Info for Doc.Daneeka

gunto It can potentially be used to help those patients who are still suffering because they haven't cleared the virus. The same argument that sees Shionogi included as the first Strive candidate - and Paxlovid included on Recovery. Viral clearance - is what they're at. Almost entirely directed at recovering hospitalised patients as once people are released there's no way to see if the virus has gone. Synairgen has data that would support inclusion on STRIVE or Recover - but given both aree FDA programs you'd think inclusion on Strive would answer both questions.

It's not a long shortlist though - which is the main reason we should be hopeful. Monoclonals do not work in hospitals. Steroids do damage if administered too early. Protease inhibitors will be investigated for their potential to stop the virus replicating - which we know it still is in LC patients, and by extension in hospitalised patients.

Doc 83
Bamlanivimab was the first Activ 2 candidate announced in August 2020
Brii 196& 198 was announced in Jan 21
SNG001 and 3 other candidates wre announced together in Feb 21.
Bamlan had finished both trials and been and been approved by November 20 - long before the second trialist began and had its EUA removed in April 21.

Doesn't matter about being first as long as they already have 2, 3 or even 4 others to add to the trial in the next few months and as long as SNG is one of them. Obviously the earlier we're on the better access to patients we'll have.

yep - and maybe even consider the only existing candidate with decent at risk sub group data in hospitals. From a large-ish trial that fell just short.
Ensitrelvir's inclusion is the exact opposite of the targeting of the most at risk patients that Strive should be concenrned with, and that so much research has pointed to. We know most people survive Covid but surely Strive should be trying to do some thing fundamental for those who still find themselves in hospital with severe respiratory symptoms. Ensitrelvir might pass the trial and be added to SOS for a very marginal gain for all hospitalised patients - like Remdesevir - whereas out drug, if the post hoc for Sprinter can be confirmed, will save all sorts of the very vulnerable people who'd get no real help from Shionogi's pill.
It's so obviously and provably true that we should be on STRIVE that I'll stick with it and continue believing that Plan A is still the best one. That we have a Covid drug. This changes at Christmas. If they haven't chosen us by then - they won't ever choose us and we'll be looking for something else.

stick with this thread chaps - don't waste your breath on the heshe.

Nah - he was dragged kicking and screaming into it. Same playsheet as Boris in the early days. It'll fizzle out by Easter.
Congress has already held up the $30 billion extra funding Biden asked for.

Not a concern for Synairgen though - or at least not one that would stop them saying yes immediately if they were invited to the party.

All the President's Lies
https://www.theatlantic.com/politics/archive/2020/11/trumps-lies-about-coronavirus/608647/

"their choice of the first drug is somewhat surprising....I really will be amazed if this drug works for a patient that needs hospital treatment...."
Sorry Mani I must have misread that - I thought you were saying it's the wrong choice.

Fruits The sounder logic says that if Synairgen was on STRIVE and it was stopped by the new anti-science mob Synairgen would still be in a temendously strong position. It would have the validation that got it onto Strive - and in terms of finding a new partner that would be gold dust.
If STRIVE was offered to RM now he would absolutely bite their arm off. And if he didn't - his shareholders, particularly Polygon would want him gone that same day.

And of course they can still be on Strive and keep working on other stuff, with other partners. NIH would not stop them

Manifesto's opinion that NIH has spent all this time and money to select the wrong first drug on its flagship new Covid trial.
She'd be "amazed" if this drug works hahaha....
I'll leave you to it Mani. Hope your JV comes along. "we're in such a strong position" after all...

Hope even more that we're the 2nd or 3rd candidate for STRIVE -and believe we will be.

"They have already stated that SNG001 should go to P3... So not to proceed would reflect badly on them
not on SNG..... "

this is false - SNG was passed for a P3 on a platform that was discontinued. In the outpatient setting. NIH has never stated that SNG should go to a P3 unless you mean passing the P2 on Activ. When A2 ws closed down they said they would explore the possibilities for advancing the drug. They've certainly never said anything about the inpatient possibilities for SNG.

Fruits - Trump will run again if the Republicans win the key state midterms. Matt Frei said yesterday on C4 that being President is his only option to stay out of prison. Not for the Capitol invasion but for the multiple tax frauds that are almost certainly going to now result in criminal prosecutions. There's time before this happens of course but if Congress is controlled by the GOP after next Thursday, funding for Covid research will come under immediate pressure.

"to have all your eggs in one basket that you don’t control isn’t a good business case " there isn't a visible business case at all at the moment, and NIH has never procluded drug companies from involvement in multiple trials to my knowledge. What they do is make you agree to give them the first batch if it works - and they pay well for that. Synairgen can't control this protocol - and it's not ideal - but if we get on it will get us to the finish line. We'll dose 450 more patients with SNG than in Sprinter and lose no control whatsoever. We might even get an interim result that stops it.
The SP would double or treble instantly, making the company more secure and guaranteeing its future.

The other options the company hopes to explore are for other possibilities such as COPD or Flu - but if NIH does not think our data is worthy of further support and investigation for Covid right now on this trial - then neither will anyone else.

Sorry - Shionogi patients don't even need to be in ICU - just on the Covid wards. They'll be handing the tabs out like smarties at a kids party.

Tommy well done for updating us earlier about Shionogi. Everyone said thanks to you then. Not sure why you see the STRIVE announcement as " bad news" though. Most of us are relieved it's underway - and you might have even said the same yourself yesterday.
If you'd brought us the news Mani would have been first in line with another of her encomiums. Keep up the good work.

Trial completion dates are never a true reflection of when they are expected to end. It's impossible to gauge how long it'll take Shinogi to dose 1500 but i bet we will see interims or LPD by Easter or summer at the latest. They're gonna give the tablets /placebo to everyone who walks or is wheeled into ICU. No patient is going to say no and there are hardly any exclusions.
1500 for SNG would definitely take longer but if hospitals are filling and there few other trialists competing for patients (you wouldn't want to be the 4th or 5th treatment announced) then it could still be fast.
Size and Protocol are 2 genuine issues with Strive however.
Size because we are reasonably certain that we only needed a couple of 100 extra patients for Sprinter to show statistical significance. RM said the PT Synairgen would look for would most likely need 1000 patients.
Protocol because STRIVE is not targeting the sub group that showed most efficacy in Sprinter - we really want 800-1000 carefully targeted patients with a protocol designed around the P3 post-hoc. BUT - if we did this we'd be dramatically cutting down on the number of patients that fit the criteria and therefore recruitment, even with a lower final figure, would be slower.
The criteria for STRIVE - all adults admitted with "symptoms of respiratory infection" is pretty broad but would still catch most of the patients we need. Those symptoms would at least include breathlessness and very often low flow oxygen. So we'd still get the statistical signifance and in my view in a much quicker timescale.
I can see JVs for other things but if a big pharma likes the drug enough to support a £30m Covid trial - it will just buy us.

fair enough Doc. Just can't see a JV for Covid. If they like it enough they'll buy it. Posible Synairgen will find other little JVs like the Jannsen one for other things, but Covid is PT or TO - that's it. And it's gone on long enough. 20 years is long enough for the company - 50 years far too long for SSH. Get something done this winter for Covid or pass it on.

It's not a fair comparison Doc83. Both of the smaller JV partner companies were already very successful and valuable a, and had been engaged in many partnersips and trials before Covid. They both specialised in mRNA vaccines when Covid arrived which proved to be the most effective of all those being trialed. Pfizer went to Biontech - which was a small but successful research company to help develop its vaccine candidates using mRNA ( Biontech's founders had already sold a previous business for $1.5B a couple of years earlier and its Mcap at the start of 2020n was nearly $9B ) Moderna had been working for more than 10 years at a very high level on mRNA candidates for various diseases and its Mcap before Covid hit was nearly $7B
So - not reasonable comparisons.
No big pharma would ever spend the same money on a large Covid trial JV -when it could acquire the partner for the same amount of cash. Synairgen has the patents but no other power in any discussions that might be ongoing. If Sprinter had been successful then the company could have gone on to become the next Moderna but those hopes are long gone and impossible to achieve from this position.

For what Tommy ?

It was a winter metaphor Doc83 - rather than the gun going and the runner leaping from his blocks I saw a skater and then canals and polders.
Polders was pushing it a bit maybe.
V. Happy tonight though - First time I've seen good news for a rival and welcomed it - except when it meant lives were being saved. I didn't doubt STRIVE was going to happen but you just never know do you. They will choose SNG.

Just imagine if we are included on STRIVE - but after a longer wait than expected, and get the announcement on Feb 20th.
That would be a truly chaotic day

The idea that Synairgen have something better than STRIVE up their sleeves is laughable. Acceptance onto it would give instant access to the NIH's huge global trialing network, and success would lead instantly to EUA in the most important jurisdiction in the world. Neither would the NIH stop the company from running other trials with other partners. NIH encourages this as it's usually the fastest way to gain complimetary data. Plenty of evidence of this across a number of drugs. Synairgen may well have other irons in the fire - or the hopes of them - but nothing else will get them across the line quicker for Covid - and nothing but Covid would be as conclusive and dramatic a proof of its broad antiviral aspirations than a headline making trial that shows SNG has been the missing link all along. If we already have a partner fpor COPD or Flu - for example - they'd be delighted to hear that a Covid trial was also in the offing.

Having said this - it's certainly not a problem that Shinogi is first. NIH was waiting for the deep dive data from Sprinter and that - in normal trialing terms - was delivered very recently, and is yet to be peer reviewed.
The gun HAS gone though - and of course, despite what others have said about the winter not being critical to the next Covid trial - of course it is and the first racer has his skates on and is away across the polders.
The protocol is settled - it suits us well enough and I think we need to know by the end of December - possibly stretching to the end of January when infections will still be high - that SNG is on this trial.

Hopefully NIH has its next candidate or candidates ready and waiting. And hopefully SNG will be one of them. NIH will not owe any allegiance to a drug just because it's spent money on it but it will continue to investigate a drug that passed that trial and has provided extremely compelling evidence from its own P3. NIH accepted SNG001 onto one trial - and the drug passed it and I believe we'll find out in the next month or so if RM's original statement following the pausing of Activ 2 - that the company and NIH were working together to find the correct way of progressing the drug was wishful thinking or evidence that NIH really does like it.