Member Info for ChrisToffer

Interesting that the EU clinical trial register hasn't been updated yet. As I understand it, that's the one that SNG are responsible for.?

Interesting that the US national Library of Medicine website were able to jump the gun here.

With that update to the .gov website it may force their hand early on an RNS. There is likely to be a lot more to it than what we're seeing.

How often do large Pharma sign up to a licencing agreement with a timeline through to final approval of 9 months? Gotta be one or more on board at this stage!

What is a pivotal trial FDA? "A pivotal trial or pivotal study is a clinical trial or study that intends to provide the ultimate evidence and data that the FDA uses to decide whether or not to approve a potential new medicine."

What we're looking at here is the rough timeline to final approval application (May next year). That's really good news!

It appears the jury is still out on emergency approvals and licencing. Exciting!

Graham that is incorrect. Summer was COPD and the home trials are dependent on the prevalence of the virus in society. Despite RM saying next month in an interview on 20th July, there is no guarantees on both those fronts that we'll see an RNS today.

There is a guarantee that they are working hard to deliver though! We need to let them get on with it!

WedME, you're confusing the Covid home trial estimated completion date with the COPD results readout that was due in'summer' but RM quote as 'next month' in an interview on 20th July.

Morning all! Hewhodares1, There isn't a phase 3 of SNG001 underway. We await news of what is to happen next with regards to trials/approvals.

Meelie, I wouldn't be too disappointed yet as I think they're all still on that learning curve.

For example, the INEXAS trial was circa 2015 and before they had effective testing to determine if an exacerbation was viral or bacterial. It still demonstrated improved lung function.

Additionally, it wasn't until 2018 and the failed Traumakine trial that Faron realised that corticosteroids as standard care acted against the Interferon treatment. It completely derailed the trial but they're going to run it again (presumably without corticosteroids).

From my limited understanding (and i'm happy to stand corrected); There is a long way to go to understand the interaction but there may still be a balance to be struck between interferon and corticosteroid use. E.g Interferon for proactive use and steroids for reactive

Meelie/Algy/Manifesto, this is a really interesting discussion, demonstrated by the failed Traumakine trial. I think the relationship between Interferon and corticosteroid use is still not fully understood? Does early interferon treatment alleviate excessive inflammation therefore negating the need for steroids? (The answer is beyond my limited knowledge btw)

Thankfully the traumakine trial happened a while back so the knowledge could be applied to these trials.

Oh FFS! So this week we've went round the buoy again on patents, fundraising and now the AZN question. Try reading the RNS's Kiwi.

I disagree there was a leak. We can try to attribute volume patterns on that Friday all we like but the fact is it finished 4% up on the previous 2 days.

Seb, if it were because either of those reasons then that would suggest a leak. A leak would be very uncharacteristic given there wasn't a whiff of anything on the Friday before Manic Monday.

You've been here long enough to know that balanced debate is welcome but you keep defending posters who clearly have an ulterior motive. Also, you keep suggesting there is something negative going on in the background and I thought you would have learned a lesson on that last month?

Price manipulation? the SP doesn't have COPD factored in yet.

In the webinar on the 20th July RM said next month. You'll have to find it yourself unfortunately.

"RM has said they have a 'cluster' they are talking to, they are a data driven company, not a bs driven, social media frenzied group."

Comment of the day CG!

It was released to either allow someone a cheaper entry here or peddle another share at a cost. The fact it was released in conjuction with a load more crazies turning up here would suggest to me that it's the former and is actually really encouraging for me.

2 articles in a week. That says everything about their motives.

Me too! RM said, "Watch our results!" He wasn't just talking about the hospital trial.

Thanks Mat! They've also said they have been working closely with regulatory authorities throughout so the trial size will have been optimised to give them the best possible chance of progressing from here. Fingers crossed for news this week but if it doesn't come I'll not die in a ditch over it :)

Thanks Matml74! Some of us are probably getting sick of repeating this stuff.

I wonder does Richard include the COPD numbers in that '200 patients' he refers to? If he doesn't then on completion of the home trial they'll have a dataset of over 500 patients.

Interestingly, they're conducting an interim analysis on their double blind phase 3 trials after recruiting 195 patients. They will have a readout mid October. They had 60 patients for their phase 2 trials.

With COPD patient data SNG are not far off those numbers now.

https://www.proactiveinvestors.com/companies/news/927591/cytodyn-reaches-patient-quota-for-phase-3-leronlimab-coronavirus-trial-analysis-expected-in-four-weeks-927591.html