Member Info for Scinv_temp

"Otherwise, I would respectfully request that you desist from adding unhelpful comments, with no foundation whatsoever, to this board."

Totally agree with that TLW. It would be good if you gave an example of a comment with no foundation in this thread.

No miss nosaj, you read this

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Scinv_temp

Posted in: SNG

Posts: 309

Price: 154.60

No Opinion

RE: Covid Play/COPD17 Apr 2021 16:08
This is what they feed investors

http://www.pmlive.com/pharma_news/positive_copd_data_for_synairgens_sng001_supports_covid-19_programme_1349008?SQ_DESIGN_NAME=2&

He added that, despite the encouraging data in COPD, this particular programme will be paused as the company’s “immediate priority” is to advance testing of SNG001 in COVID-19.
In September 2020 they communicated some results from the interim analysis but they still suggested the trial was "paused" even though clearly it did not look great

However, this is what they told the activ 2 people who they can't be fed with bs

"Originally, up to 120 patients in total were to be randomized during Part 2, however, due to the SARS-CoV-19 pandemic in 2020, the study was paused and an interim analysis was conducted of all currently available data in order to aid decision making with respect to the potential of SNG001 in treating and preventing COVID-19 symptoms. At this time, 109 (placebo, n=52; SNG001, n=57) patients had been randomized and following the interim analysis a decision was made to *close the trial*. "

"Although there was no statistically significant difference in total BCSS in this group over the treatment period, there was a trend towards improvement of the breathlessness component of the score, suggesting that patients may have recovered more rapidly if they received SNG001 rather than placebo. Viral infections had less impact on non-exacerbating patients and there were no significant treatment effects. Biomarker analysis showed that in the overall population COPD patients inhaling SNG001 had significantly increased markers of antiviral activity."

These are from the activ document in the background section for sng. The second part they also published in an RNS last september, as you can see there is a "suggestion" but not really conclusive. More importantly, in the first part above, they clarify that they initally paused the trial and then *closed* it *after* the interim analysis. They never told this to investors directly afaik but do correct me if I'm wrong. So they have to do it again but better. Once again, it seems to me if there were enough patients with exarcebation it would have been enough to apply for a phase 3 but now it does not seem to.

Oak you already know that they closed the trial after the interim analysis and what that analysis showed because all of thatvis described in the activ documents. So not sure what you mean.

They paused the trial then did the interim analysis, they only saw some suggestions and trends that did not reach statistical significance and then they decided to close the trial after that. If this means anything else to you, fine, but that's just you :)

And that they already have a failed asthma and a failed copd, both viral infection related, right?

You do realise they have to do trials for that and outside of covid they take years, right?

Just like he favtored in the 100K treatments from Jan? Atbthe end of the day he said Q2ish and this means April is just your speculation

I'm sure activ 2 are very organised and focused. On the other hand they could not use all the recruitment sites they wanted to because RM did not have enough juice.

But, why limit yourself when you can both charge high prices and for everyone. This is the "stroke of genious" lol

K-mac, enlighten us.

Also the argument that I read in the weekend (I was banned until this morning) that there were too many patients in Jan/Feb and that is why the trials did not progress is ridiculous.

However even more absurd is that it would not make financial sense to limit themselves in the first instance to patients with pre existing or early formed ifn a antibodies. These people amount for about 10% of severe hoapitalised cases so though they are not that many in general they amount to a sizable proportion of burden on health systems. But I guess 10% of hospitalised is not enough for RM who wants to save humanity.

Here is the irony, a drug that is very targeted to a specific population that is relatively rare can justify a much higher price than a drug that is addressed to a very large proportion of the population and health authorities do not argue against it (it is perfectly normal) as long as the drug has high efficacy and safety.

But the world is not enough for SNG so they are going for everything, despite twice shown not to have enough of the juice.

That exactly the case before covid with a pps of 10p. What is new is covid and that the copd phase 2 results weren't great and they closed the trial. So if you remove covid the new thing is that the copd only showed some suggedtions and trends.

Don't listen to me, listen to RM.
First he could not believe that it showed positive results in patients on oxygen, then it was all about early with HT and activ 2, then oxygen again because it needs a fire to put out, then TW comes out with plans to do trials in ICU which apparently RM also suggested in the past (but they did not want the RECOVERY platform). They totally know what they are doing.

But at least I'll be fair. This isn't straightforward, it is you who likea to pretend that it is.

There is no restarting to completion. They have to do the phase 2 again until they have conditions under which the trials can generate good enough data to progress to phase 3.

Good to see that you understand that there are risks. Then obviously you understand that it may not work and that obviously relates to science, some of it we discussed today with opportunity of matt posting that paper. Yet you still insinuate that the the science is fully supportive without actually saying it.

Reminds me of someone. Are you sure you are not RM? :)

I look forward to hesring about synairgen and "operation dragon" and how that relates to the sng001 and covid.

Ghia, actually the last time we discussed these things this is what you told me

"Ghia

Posted in: SNG

Posts: 2,047

Price: 146.10

No Opinion

RE: Human Behaviour20 Apr 2021 22:52
Scinv let’s talk risk then.

What the biggest risk to SNG? it fails to receive approval for its drug completely.

This risk is independent of Covid, independent of competitors etc.

It relies primarily on the outcome of the Global Pivotal P3 trial.

Now I challenge you to find one scientific publication that indicates IFN will not provide a benefit in this trial situation."

So you it was so clear to you that either ifn a is just as relevant as ifn b if not impaired by antibodies (the majority of even sever cases) and that if these autoantibodies appear very late then they not not in fact be an indication of the benefits of ifna or beta and that it could be irrelevant in those cases. Then why did you not identify those risks only a couple of days ago? Either you are lying about what you understand to intentionally mislead. Or you simply could not identify the above as potential risks. Which one is it?

Another clarification, one of the favtors that we do know plays a role in promoting severe disease is vital load itself. With higher the initial inoculate, there is higher chance to get severe disiease down the line. Viral load can also be increased by increased replication of the virus that is already there, and if ifn is impaired then you do expect more replication and viral load.

Anthony, when antibodies block ifna then ifn b can bind to the receptor. OH. MY. GOD. You have just opened my eyes to the truth

Spinaker

On the first part.i have no obligation to be a saint. This is an abusive board. PERIOD. In fact, way back, I showed a tonne of tolerance this abuse. I don't have to do it in perpetuity, I am not claiming any good person of the year awards either.
Understand this also, speaking with confidence about highly specialised and complex science when in fact not a scientist is in itself arrogant. Again, not claiming any awards, but if all you see is arrogance coming from me then you are blind. At least I am actually a scientist and in drug development in particular.

Second: My view has been this for a long time, screen them after infection (so as early as possible how far before is no longer consistent with anti viral mechanisms no one can tell exactly, but icu stage is by far the least likely) and then treat them, you want to treat everyone in the trials to sort out what's best, even better but CHECK. I jave seen no narrative or document from the company that suggests they are screening for deficiencies in their own trials. So I assume they do not.

Activ is far more clear.
They don't just check before treatment, but throught the primary endpoint monitoring period. This will answer if in some people auto antibodies are present already earlier and if not, when. Maybe there will be a mix of cases, who knows? That's why you have to check. In those cases, the earlier the antibodies are there (ideally as soon as they tested the first time) the more likely it is that they are in fact causative of severe disease (if patient on placebo actually get severe disease). If they only find cases where these showed up towards the end of that monitoring period and the patients became severely ill at the same time or shortly after, then there is a good chance this not causative or a driver but simply a symptom. This information will obviously inform the design of the phase 3, either the inclusion criteria and/or the number of endpoints (if they make separate ones for + or - minus antibody. Note that primary endpoints have MUCH greater value (especially when it comes to marketing authorisation) if they are pre-specified. They are also checking ifnb as well, for the same reasons but probably it is also a tick in the safety checklist (they want to see if the using the drug induces autoantibodies against said drug, which would mean autoantibodies against the natural protein as well). I don't think there is a big risk here, it isn't unheard but seems less likely to happen for ifn b.

Blessed if you noticed, most of the people here don't even grasp the concept of sizing a position, it is either hold or sell. And yes, all of that is very common in message boards, public or private but people still do it anyway. Human nature...