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It’s a good discussion but, again, it’s all guesswork.
The science works, let’s trust that RM and his team know what they’re doing.
Not long, for sure.
The thing is activ has multiple drugs and adding new ones while the status refers to the whole trial platform. So I guess it will switch to "not recruiting" when they decide to wrap the whole project but not for individual drugs.
Yes, isn't obvious from what } wrote that we don't know? I did clearly say it could this or it could be that, isn't that self explanatory?
What I did try to do is to discuss how the placebos work in the activ 2 trial, using the information that they published.
Scinv,
You said "So it could be that it is 1:1 or it could be that it shares placebo with another non infused agent etc" - doesn't that mean that we simply don't know, and everything is therefore conjecture?
That's what the activ people say, not me. So that is what we know.
Thanks for filtering, hopefully now I won't see you reply to my posts since you can't see them.
These are described on pages 62 and 63 of the master protocol. The figure earlier in the document is meant to outline the concept, not to describe all possible scenario. For example, apart from low risk/high risk there are other criteria such us time since symptom onset etc. So it could be that it is 1:1 or it could be that it shares placebo with another non infused agent etc
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.
Activ 2 is a shared group of placebo. This is not a 1-1 ratio. I believe it is a group of 200 participants split amongst all drugs.
*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
Queeny66 - it’s one protocol covering all ACTIV-2 candidates. So referring to the protocol for trial completion is fruitless.
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.
Dpc . It was shown recently that you have to employ a placebo that mimics the drug in side effects as was demonstrated recently but I can't recall the drug being tested. ( although I think it was a vaccine) The drug gave patients a sore arm .If they didn't get the sore arm then you'd know it was placebo so the placebo in this instance was a drug for a non related disease which caused the same sore arm after injection , Therefore minimalising " placebo effect" .That is as long as you tell all concerned that they both have same side effect . I know sng 001 is not injected but it highlights that placebo isn't the same for every trial .
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.
Had it not been for the WHO banging on about interferon making no difference without clearly separating injection from inhalation and the fear around cytokine storms before it was shown that interferon beta did not drive the Ace2 process causing that issue, we would in my opinion have had EUA last July. None of this was in the control of Synairgen
Scinv_temp - so this juice you’re referring to. Is that something that Akron or Rentschler produce or does that come in at the fill-finish stage and is supplied by Catalent or Thermo Fisher?
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.
Tonlin
Take a look at how many treatments have been approved. I don’t think there’s one and probably less than 5 that have received EUA and we’re talking about some giant Pharmas
Synairgen are absolutely knocking this out of the park given their size, finances and influence
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?)
ah that makes sense, thank you! apologies for my poor grasp of the terminology
I would suggest the reason Han**** placed his AZ order prior to any P2 was more to do with being at the front of a very long queue. After all, it is first come, first serve. I think I'm right in saying the other therapeutics out there are taking equally long. All will be ok
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