Member Info for Scinv_temp

Loool.

Can you specify the legal reasons. By the way, one still needs to register to view the playback.

Looool it was a publuc presentation you fools, the people who asked questions live called in soecifically for that

1. They do show some non significant but encouraging reduction in viral load in that paper ftom 2014
2. Biomarkers are about PD modulation, this is to show that is there and active, and they can and have shown this in healthy volunteers before. The viral load is to show that this activity results in less viral load.

If you are sure that they have more data then I am not sure why they are not showing it, going as far as to present in vitro data from other studies instead of doing their own with their own drug or hiding a reduction in viral load from phase 2.

Meelie. That's absolute nonsende

Still nobody cares though.
6.3.13 Virologic Studies
Anterior nasal and NP swabs and plasma will be collected for quantitative SARS- CoV-2 RNA, performed in near real-time.
Influenza and other respiratory viral testing may be performed on stored NP swabs.
Additional information can be found in the MOP and the LPC.
For sng001 staff will collect NP swabs at fixed intervals starting from day 0 (there are also self swabs daily but this might be less relevant) and also blood test for viral rna at 0 and 7 days

Nobody cares

Lol. First of all pahse 2 is not just about home and secomd nobody said that it is easy. That's the job.

By the way, I just noticed they removed the Q&A from the replay of the conference call, it wasn't the case a couple of hours after the call had concluded (I did watch it again shortly afterwards and the Q&A was there), and I don't think I've ever seen that before. Not sure wth they were thinking.

And by the way that figure is taken from
Mantlo et al. Antiviral activities of type I interferons to SARS-CoV-2 infection. Antiviral Res. 2020;179:104811

"Vero cells were pretreated with human IFN-a or IFN-ß (0, 1, 5, 10, 25, 50 U/ml) for 16 h and then infected with SARS-CoV-2 at an MOI of 0.01. Viral inoculums were removed and replaced with fresh media containing listed concentrations"

And it shows what happens if you pretreat the cells with IFN and then infect them with the virus, so it is not even the in vitro version of reduction of viral load and they didn't even do it themselves.

Activ are checking viral load as well but that is ongoing, my question was on the whereabouts of the data from concluded trials.

That was in vitro. And it would be interesting to see if they have demonstrated reduction of viral load in any human trial.

People keep talking about the science, but this isn't something abstract to be talked about, it is something to do demonstrate mechanism, efficacy and safety.

"Virus clearance/load (if samples are available) [ Time Frame: Day 1 to Day 28 ]
Time to virus clearance and viral load"

This was part of the phase 2 protocol. Were there no samples available at all? If it is one thing that an anti-viral needs to demonstrate is reduction of viral load, that is that it is in fact preventing the virus from replicating or accelerating clearance in humans and in the way the specific drug is used. Though, viral clearance may or may not lead to reduced progression to serious disease or robust clinical improvement the way and in the patients a specific drug is used, it is showing that the drug has the expected effect on the virus so it is demonstration of mechanism of action.

Similar to above keep in mind that breathlessness did not necessarily result in hospitalisations in the phase 2 home (did not directly translate to hospitalisation or severe disease). So it is still unclear to what extent improvement in that score will prevent icu or death or quicker discharge from hospital.
Nothing here is certain. And to me sng is light on clinical side of science.

The thing is, they need a minimum number of patients to see a significant trend that is then confirmed in a larger phase 3 that is designed based on the informstion from phase 2. For a phase 2 you can change it as you go but you still need to get to that minimum number of patients with a specific protocol (including inclusion cirteria) so either in the end you have a larger trial even if it is shaped as it goes to the whatever final protocol or it is a sloppy trial with a predetermined number of patients that were treated or selected in 2-3 different ways. So the first takes longer and is more expensive while the second is reslly not a good idea most of the time. This can happen in phase 3 as well to some extent but for registration, the protocol needs to be prespecified and tested in large enough number of patients (usually with guidance as well from whatever regulatory body you want to register the drug with), ideally one would have sorted the protocol in phase 2 but the same applies for phase 3, you can change but unless you do the required recruitment for the final protocol the there is an issue. This is particularly problematic with triple blind trials which is what is required for this drug. One example triple blinding is not a requirement is for example the second wave of vaccines that may be approved based on proving similar or superior immunogenicity (based on an objective measure) relative to another vaccine which is already approved. Something similar can happen with drugs, but because there are no other "equivalent" approved, bilded placebo controlled is the only way forward (so they can't monitor continously), and in any case it has to be with a prespecified protocol and primary/secondary outcomes.

They should have at least had some music in the background, effects between slides (BOOM!) and a naughty ballet performance between presentation and Q&A

It was meant to be understood by anyone with exposure (in terms of experience) in clinical stage biotechs, not necessarily scientists but anyone with experience in looking at this kind of data regardless of their training.

There is usually an aim for balance between making it understood by non experts while still presenting important details in a proper way. Like you said, you understood even though your training/experience is not related to drug development, that means they weren't far from that balance. People who don't get what "n=" means perhaps they can take the opportunity to try and learn something by researching themselves, the level was appropriate in my view. Not sure how to say this without it sounding like "attitude", but hey, if some people don't get the most basic stuff about it and can't be bothered to at least try and learn themselves, maybe they should invest in something they understand better right off the bat.

I did not find it weird if I didn't get basic things when I watched a decade ago a presentation on out of order execution microprocessor designs (the broad field would be electrical engineering) that was meant for investors, not scientists in the field. It meant I was not ready and having spent more than a year trying to get the gist of the field ("gist" is probably an overstatement) while very cautiously opening small positions in some companies, I realised it was in fact extremely simplified.

Fun fact, in a codx conference call (another company it did not invest in but was considering much earlier in the pandemic) had a conference call (probably one of their first ones if not the first), there were dogs barking in the background, a guy shouting to his wife, a woman trying to shut up some children, several people in the zoom call laughing or asking WTF etc.

There is always room for improvement, and I personaly have not seen another "proper" conference call from them so I suspect it was their first one. Also, I still don't get what you thought was not clear, there is always information not presented, but what do you mean in this case?

You think that the people who asked questions live were random? They weren't, at least not all of them.

No Ghia. One thing that you have to take into account is that there were analysts and representatives of funds in the conference call and that is how they want it delivered. You know, the ii's everyone likes to talk about here? Great excitment needs to be accompanied by recent material developments, that they did not have at the time.

Doc, then again if I'm not mistaken, you said this was the first stock you ever invested in, so have you asked yourself how would you know how it's supposed to look like?

There is always "better", but to me at least this was normal.