Member Info for HelloSanDiego

Hi, I have a quick question for anyone with more experience in clinical drug development than I do:

If a drug misses its primary endpoint (time taken to recover) in a large, phase 3 trial but shows statistical significance at reducing mortality, is the failure to hit the primary endpoint likely to do much to reduce its chance of FDA approval?

May 2022 - "Researchers found the risk of progression to severe disease and death compared to a medicinally inert placebo was reduced by 70% by taking SNG001."

It looks to me like the protocol they're already using for STRIVE is a good way to measure that. I think the 'time to recover' endpoint would be tough for us. But if it shows a significant reduction in mortality and the need for mechanical ventilation, I'm assuming that would be enough for approval.

Manifesto - "If a JV trial was halted early due to good results we could be applying for EUA long before STRIVE is complete"

And if STRIVE was halted early due to good results we could be applying for EUA long before a JV trial is complete.

Gunto - "There is more than one protocol for STRIVE"

I didn't know that. Can you tell me where you found that, please?

Doc Daneeka - "I'd prefer a different trial protocol"

I was under the impression the design STRIVE was using would be ideal for SNG001. Which parts aren't you happy with?

Manifesto - "So now look at a JV that could start at the same time as STRIVE.... Which do you prefer???"

STRIVE, obviously.

For starters you've ignored the fact that even if a JV were agreed today it would take months to submit a trial to the FDA and get it approved. So STRIVE is already way ahead in that respect.

And aside from that, if they can get this to market without a JV why would they agree to a deal that could see them giving away over a billion in profits for a chance (and no guarantee) of saving six months?

Manifesto - "BP is mulling over a JV/TO with/of SNG"

I can't help but think that's a really dumb suggestion.

If Synairgen gets on a $40m trial that is funded by the NIH soon, why would it contemplate giving away a large chunk of its profits in a JV? What would they have to gain from it?

I think the crucial point is that they are already in the process of adding more than one new drug to STRIVE.

Our chance of SNG being one of them is high, in my opinion. They're obviously prioritising drugs that are in development and I think ours meets the selection criteria laid out in the Duke edu pdf.

https://dcricollab.dcri.duke.edu/sites/NIHKR/KR/GR-Slides-07-15-22.pdf

Thanks for posting that. It's literally the best news we've had here all year.

The emphasis on inpatient trials would definitely work in our favour.

*EDIT: I forgot to delete the part of the post I rewrote.

It's not the news we were hoping for. But I was sceptical that SNG001 would be at the very top of the list anyway.

I'm much more confident we'll be included if they add another one or two drugs to STRIVE.

Well it looks like Shionogi knew at least a month in advance they would be part of STRIVE.

That means

Ghia - "My maths has Poly sub £1."

Same here. It seems that what Tommy lacks in knowledge and judgement he makes up for by posting a significant amount of opinionated rubbish.

Lebus - "SP closed today at 17.50. Talk of 35p a little premature maybe?"

Or maybe not.

Don't you think they already had that discussion six months ago? There's nothing to gain here from being the last to know.

I almost forgot:

Access to paid, expert consultants
Contacts in the financial and pharaceutical sectors

...there's probably more but hopefully you're beginning to get the point.

Tommy - "The idea that Polygon have some magic knowledge that allows them alone to move forward with interferon treatment is for the birds"

Magic knowledge?

Here's what they have:
Over a billion pounds at their diposal
Nearly 30% of the company in their hands
Control over when and if the company gets to issue more stock

If you're one of the people sitting on a 90% loss I can understand why you'd argue that a genuine possibility isn't possible. But you're better off facing facts, in my opinion.

So why would they decide a 30% stake is a good number to aim for?

Fruits - "Why would they do that HSD?"

If they can buy the entire company and finance a P3 trial themselves, they could have a drug with sales of over a billion pounds every year for another £150m invested.

Big risk, enormous reward. But they've already put in another £5m since the unsuccessful P3 results, so they're obviously willing to take a risk on it.

And why would we just assume they want to stop at 30%?

Fruitsnveg - "I don't believe Polygon would let this go for 50-70p. "

I'm not certain I agree with you there. But what I meant was that Polygon could be planning to put in a 50-70p takeover offer.

I definitely think there's a possibility of a 50-70p takeover next year.

To put it another way, it's definitely a possibility. The only question is how probable it is.

Tommy - "I tried that but she didn’t bite"

It sounds to me like it isn't yet finalized then.

I think Shionogi's drug looks like a good candidate for STRIVE, having seen the selection criteria. But with the other trials they've got it on, another one looks a little redundant to me, especially if the Activ/Strive bodies feel SNG has potential that might go unfulfilled mainly due to bad luck.

Shionogi also released their half-yearly results yesterday (link below). It appears to say the same thing about STRIVE. But, interestingly, they also refer to it as being another SARS-CoV-2 trial, even though everything I've seen points to it targetting several respiratory viruses. Maybe they're just bluffing a little bit.

I'm normally against bothering doctors to get investment information. But since Shionogi appears to have announced it, that guy on ADVFN shouldn't have a problem getting Dr Adam to confirm it if it's true.

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/e_2q/e_wide_2Q_20221031_v2.pdf