Big question mark regarding vaccines. You may remember some days when Fauci tempernd the expectations regarding a vaccines when he said: „the efficacy of vaccines may be as low as about 50 %...“ ?
You just for comparison: the least effective vaccines on the market are against flu (about 70 efficacy), hepatitis A or B are around 95 %. Tetanus almost 100 %.
Two articles which fuel skepticism that we may get a safe and efficient vaccine:
1) EFFICACY: normally you are protected at least for a while if you have been infected with a virus, because such infections induce a strong immune response and you get neutralizing antibodies which will protect you (as long as these antibodies and so-called „memory cells“ last. Apparently NOT here with Covid-19. Only stunning low 60 % develop such neutralizing antibodies.
https://www.meduniwien.ac.at/web/en/about-us/news/detailsite/2020/news-im-august-2020/covid-19-not-all-patients-develop-protective-antibodies
This remarkably low. Normally a vaccinations is inducing less immune response than the infection. This could explain why Fauci has such low expectations about Covid-19 vaccines.
2) SAFTEY; you maybe aware that despite many years of research no vaccines could be developed against some virus infections And one of the reason (e.g Dengue, or SARS) is that the immune system reacts adverse via cytokines and strong induction of the so-called „complement system“ - the effects are much worse than the effect of the direct effect of the virus itself.
Here a description: „Since the 1960s, tests of vaccine candidates for diseases such as dengue, respiratory syncytial virus (RSV), and severe acute respiratory syndrome (SARS) have shown a paradoxical phenomenon: Some animals or people who received the vaccine and were later exposed to the virus developed more severe disease than those who had not been vaccinated...“
Cited from. „PNAS“ = an absolute TOP Journal:
https://www.pnas.org/content/117/15/8218
Maybe the strong decline of COVID vaccines of the last days has been fueled by these concerns. I need to follow up, but it seems that we are certainly not there yet, where we could say that it is only a matter of time when we will have a COVID vaccines. We may never get one.
Apart from that - i have seen already a lot of junk in some peer-reviewed journals. That per se does not impress at all regulatory bodies. The study report is what counts and you need professionals with experience to compile and write such study report. Even the very best and fastest need 3-4 weeks. Then regulatory bodies need some time to assess it - yes fast track in this pandemic, but still it takes 2-3 weeks and: neither in FDA, EMA or UK MHRA one scientist alone makes this decision - but a committee is assessing it and makes recommendation and only then the decision will be made by the authorities. Thus, what you need here is patience and trust that the study was well performed.
I agree - there is zero requirement at the UK MHRA, European Medicine Agency (EMA, Amsterdam) or FDA that requests to publish the data in a peer-reviewed journal. I have worked for EMA for 4 years (when it was still in Canary Warf, London). In fact the very most big Pharma First seek approval and only some of them publish months later in a peer reviewed journal. Why would a big Pharma publish before getting marketing authorisation? To pre-notify their competitors?
Some scientists would like to see it published on a peer reviewed journal before the give their firm opinion on that Synairgen trial, but drug regulatory bodies do not ask for that - they ask for the full study report with all data, raw data, individual patients data and all details of the trial design, GCP certificate etc. they get much more than what is ever published a peer reviewed journal.
Wrong. As long as people sell below 220 and as long Venrock buys at maximum 220 - the price will remain where it is. Now it seems that there is hardly anybody left who sells below 220 and this if Venrock wants more - they will have to spend more.
any further demand will break the 220 pence - hardly anybody there who sells below 220 now.
With the good news to come - demand will hit firm hands and a market with very few available shares. Next step short term should be 240/250 and with good news well beyond....
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)
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.
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
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“?
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
Thanks a lot. Sorry, I thought phase 2 trial was done and now the phase 3 results were to come. Everybody here seems quite optimistic regarding COPD. The potential (Revenue) is even bigger than for Covid in my view.
So we await the results from that Phase II trial (whether 109 or 120 patients hopefully does not make a big difference. Would be a pity and very unfortunate if the p- value would be just a bit higher than 0.05 because about 10 missing patients. But why are you all so optimistic that the betta-interferon spray would have a great effect on COPD ? Just from the mode of action or are there at least some limited clinical data (e.g phase I which should promising efficacy data?)
I am rather new in SNG, bought that day when the great results were published about 2-3 weeks ago. Obviously COPD would be (in my opinion) even bigger than COViD-19 and all we await the results from the finished phase 3 trial.
Can somebody please provide me with the link to the phase 2 results? Ideally the peer-reviewed journal if it was published (I would guess so)? Many thanks in advance !