Member Info for Scinv_temp

They do it to optimise recruitment, since less need for placebos means more room for treatments using the same resources. It is not clear to me if for sng it is 1:1, but if it is so what?

The criteria for grouping are 1. The trial phase (agents can share placebo if they are both in phase 2 or both in phase 3
And
2. The same (or very similar?) inclusion and excusion criteria are true for patient selections for all agents that are to be grouped, for the grouped ones they will receive 2:1 ratio of treatment to placebo.

It could be that still sng001 shares placebo since we don't know for sure. But they have put criteria on how and when these are shared so it is not automatic.

*in reference to Tatty's comment on "recent" developments about placebo, all these things are studied in an ongoing manner but what you described has been the standard practice since long long time ago

And by the way, this isn't recent at all. It has been like that for ever

True, but they are getting creative with the activ 2 up to a point. My feeling is that sng is 1:1 though, and most of the antibodies share placebos to some extent, each of them will still have some of their own placebo (2:1 treatment:placebo) to sort out placebo issues but at thr same time maximising the treatment arms.

Gbk oh really? I'm answering questions the best way I can. You seem bothered by this when in fact this is what people do here anyway. But you knoe what, you are right. Let's stick to the facts: as of end of February SNG did not have enough materials to statisfy the needs of the very modestly sized activ 2 trial. That's what we know.

In which vials, remember these are still syringes to be used for loading on the nebuliser.

It could even be a third company that makes the solution. I don't know if Akron makes large batches of final juice or the dry product or even if the dry product is already formulated with anything that is needed directly by akron and then they just add water at the fill/finsih and distribute to vials. The most likely the way I see it is that akron makes large batches of formulated sng001 and these are distributed to vials in the final volume and concentration by the fill/finish partner.

Rum I would also suggest that apart from the strong rationale for using monoclonal coctails esp earlier, there is also confidence az can actually deliver the treatments in a reasonable amount of time. There is a reason they put the "Emergency" part in the EUA.

So worst case scenario is half of the patients receive placebo and the other half treatment (100 + 100), and the best case is twice as many recieve treatment than placebo (65 + 135 or something like that?)

So they are not short of the active ingredient but they are short of the juice they disolve it in, and we are talking about a few thousand doses at most anyway. This isn't great anyway you look at it.

They do it to optimise recruitment, since less need for placebos means more room for treatments using the same resources. It is not clear to me if for sng it is 1:1, but if it is so what?

The criteria for grouping are 1. The trial phase (agents can share placebo if they are both in phase 2 or both in phase 3
And
2. The same (or very similar?) inclusion and excusion criteria are true for patient selections for all agents that are to be grouped, for the grouped ones they will receive 2:1 ratio of treatment to placebo

They take into account most placebos for the final decision regardless of treatment so what?

Matt activ people say so themselves. It has been discussed here as well and you have seen it. Maybe that attitude is OK in your trade but in the investment world this is filth. Do you really don't know where this comes from?

The "we know it works" doesn't stand from a regulatory point of view at the time it was made.

Like you said we don't know what happened but we DO know that they did have support, the government was interested and helping and were initially included in the Recovery etc but shortly after phase 2 results all of a sudden this was a £2.5K treatment, RM wanted to go alone and that gov was not convinced smg could produce significant quantities. Turns out, months later and even at least at the end of February this year, sng did not have enough juice to satisfy demand for the modestly sized activ 2 trial.

Even if it is just repurposed version of another drug all hospitals need is a valid protocol with clinical evidence that it works and it is safe, it does not need necessarily to be branded as a separate product.

You need to get over the fact that if it works, others will come out with simipar solutions. I personally invested with this in mind right from the start. Get over it. It is going to happen and not just from France. All SNG has to do is make sure they are in the mix, berhaps with most sophisticated version of it, but the important part is to be in the mix.

In any case, as Joey mentioned perhaps they could easily get overall hospitalisation without unblinding and when they do publish the results in a paper, they have to say when exactly they unblinded so we will know for sure then.

Also they could do it in some but not all the patients, 60 days over a month over the previous 28 day follow up and also keep in mind that this is a quedtionaire that the patient fills, not lab tests.

Matterhorn, if you are referring to the up to 1 year follow up, this is standard follow up that existed in the copd and asthma trials as well as all similar trials. Do we have reliable information that they had these readouts for long covid specifically, not just a standard safety follow up since February?

Thanks Joey, if you read carefully, I actually don't assume the worse, I assume as others here have before I commented, that there were not as many events as they would have liked/hoped. I think you are right that they could have derived some conclusions from the blinded info in overall hospitalisations. As for the unblinding, that's what the protocol was at the time and it took a month over the original date to update, which could be an admin delay or it could be that they simply changed after unblinding. In the latter case it counts as an exploratory readout and yes it is weak towards an approval that would rely on that even in part as it would be considered as data dredging. But like you said, they could have derived it from overall hospitalisation.

In any case, I think it is clear that my issue is how RM is handling the information they do have.