Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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https://www.nasdaq.com/articles/cytodyn-reports-top-line-data-from-phase-ii-coronavirus-study-2020-08-12
Shares in cytodyn dropped significantly on news of the trial results.
'Shares of the company fell 13.5% following the news as the investors were not impressed with the results.' according to the report. Price has gone from $10 down to $4 since June 30th.
Sending the wrong data sets to the FDA doesn’t exactly inspire confidence, see: https://www.fiercebiotech.com/biotech/fda-spurns-cytodyn-s-hiv-drug-because-missing-info
Hope it works out for you Frank but this board is about Synairgen.
I noticed Venrock and also the RNS by some managers associated or Working for Venrock - I am very happy about it, but thats all ? Not any relevant media has reported the great SNG results - even in the UK I read only about 2-3 university professors who got „rich“..... wake up, we have a pandemic !
That was request of FDA to complete Cytodyns BLA submission for approval against HIV before accepting the application and the FDA starts its assessment. Pretty much normal procedure which happen to all big pharma as well before FDA accepts an application. (Same at the European Medicine Agency in Europe bzw)
https://youtu.be/Kso8pPPuc6E
Not started yet
https://www.youtube.com/watch?v=VEtyFA-QVP8
He's running behind schedule. Or possibly hiding behind the podium
When and where can I watch trump?
This is from around a month ago https://www.thepharmaletter.com/article/setback-for-cytodyn-as-us-fda-returns-leronlimab-submission
Thanks for the nice feedback. There are good boards for CYDY. But I followed this board as well because of SNG and I saw some wrong statements here about Cytodyn/leronlimab. And I must say, it seems that nobody outside of the UK takes notice about SNG - but worse also vice versa, you in the UK have no clue what is happening in the US and Europe regarding drug development.
Very fine with me and I would very happy to see advances here with SNG. The Covid trial delivered great results, I am less convinced regarding COPD - I could not retrieve any clinical data about its efficacy - so that is a bit of lottery regarding COPD. And I only talked about CYDY because some here did wrong statements about it.
Someone throw something pointy at him
Subcutaneous injection is done by millions diabetic patients every days. Leronlimab is once per week.
Spray is will not be good for all patients - especially not for those with a badly affected lung. Such severe Covid patient you would not get Interferon Beta into the lungs. Subcutaneous injection no problem.
Wrong again, first the Phase II trials should statistically significant improved NEWS2 results in favor of leronlimab = this is a clinical marker with predictive value for worsening of the clinic
And secondly here is the phase 2b/3 Trial (started in April, half way done) on severe and critical patients:
https://clinicaltrials.gov/ct2/show/NCT04347239
Frank - I think the problem is no one here really cares about the drug you are talking about.
We are all pretty comfortable with our shares here the share price is rock solid currently which backs up the sentiment around this drug.
There will be other treatments for Covid in time which is fantastic news.
But right know the investment case for SNG is very compelling and we’d probably rather discuss that than Cytodyn.
Nebuliser vs subcutaneous injection?
No contest.
Imho
Is it fair to say Cytodyn is targeting mild cases that aren't going to get worse, whereas SNG is targeting early cases which potentially could get significantly worse
You do not need to be nervous for your SNG shares just because others are more advanced. There is the need for more effective drugs. Can you be more explicit ? What are my „basic logic errors“?
And I have filed an application to go on Celebrity Love Island, but apparently there are some fitness checks.
You missed the rather crucial
4) FDA will reject it
I have no idea if your drug works or not, but you certainly make a lot of basic logic errors.
Live press conference NOW:
https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/40223/indexl.html
Leronlimab: Apparently Cytodyn today filed an application for emergency approval to the FDA, UK, Mexiko, EU (Eiropean Medicine Agency) and Israel.
https://m.youtube.com/watch?feature=youtu.be&v=_V60NPy8uqU
What will FDA do ? 3 options
1) FDA will approve it
2) FDA will not approve it but ask phase III trial to confirm the Phase II results (with NEWS2 as primary endpoint or day 3 total clinical score). In this case CYDY should get huge OWS (US warp speed) funding for that phase III.
3) FDA will grant emergency „preliminary“ or conditional approval, but requests CYDY to conduct phase III study.
Neither of the 3 is bad .
Cytodyn today has submitted an application to the FDA, UK (MHRA), EMA (EU), Mexico, Israel for approval of leronlimab! Somebody provided the link to this video of today where NP said that they filed an application for approval to the FDA, UK, Mexiko, EU (Eiropean Medicine Agency) and Israel.
https://m.youtube.com/watch?feature=youtu.be&v=_V60NPy8uqU
Hello Frank. SNG's COPD trial was Phase 2. It was interrupted by COVID at 109 patients recruited out of 120, and authorisation was given to conduct interim analysis to potentially provide supporting data for use in COVID.
Curious what you think of the market reaction to the leronlimab topline readout? Is there something dodgy going on?
I think Remdesivir approval was a shame on a secondary endpoint. If you use a secondary endpoint for approval, normally, you would need at least to apply Bonferroni adjustment for testing multiple endpoint, and then this „hospital stay duration“ would not have been statistically different to placebo.....
I can only understand the approval because of the huge political and public pressure to approve something against Covid-19. Buu applying the normal standards (I worked for the European Medicine Agency, formerly London, now Amsterdam) , Remdesivir should not have been approved.
I am pretty confident that SNG interferon-beta Spray and leronlimab of Cytodyn work ways better than Remdesivir. Remdesivir did not even reduce the viral load in Covid patients (leronlimab did) but Remdesivir is by definition a „antiviral“ interfering with the virus RNS synthesis.... but does not cause anything but side effects (kidney, liver).
You mentioned COPD. Having some SNG shares I know of course about that COPD trial phase 3. Obviously that would be huge of positive.. please can anybody send me a link to the Phase 2 trial results of SNG on COPD ? Was there anything published in peer-reviewed journal?
Frank09,
So, leronlimab is a potential competitor to Remdesivir?