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Thanks Doc. That sounds like a great solution for getting out of this mess. I hope one day they can go further and take a puff before they even catch it (May be price prohibitive tho).
Doc - I think anticipated price and availability of stock preclude this from happening, at least in the short term.
Longer term this might be an option for lower numbers where the patient is likely to progress into hospital and/or develop long covid. I say lets actually get this to the hospitalised patients first, (On admittance), then pre-hospitalised patients.
Al, I believe the term ‘randomised’ just relates to the fact that patients are assigned the drug or placebo by chance, not whether the trial is blinded or not.
As you say all will be revealed soon though.
Mat - IMHO, they have chosen between randomized and double-blinded as two wording with similar outcome on purpose. Randomized is a more inclusive term for the trial been either double-blinded or single-blinded at the end. If I understood you are aiming for single blinded, that the practitioner knew who is in the trial group and who is in the control group.
I assume the IND submission will have different options, and there will hopefully be discussions on this before the trial commence and decided which arm is chosen.
HarChris... I am not an expert, my nderstanding is that for a drug to be accepted by the medical community as a safe, efficacious treatment for a particilar indication/disease it would have to go through separate trials (as there might be dosage/delivery method differences). That said, these tonce a drug is available out there and if delivery mehod is the same (inhalation via nebuliser in our case) I think a lot of it would ve down to the prescribing physiscan as well (need to check that but have been told something along thesenlines)
I’m quite excited that SNG could be used prophylactically (preventatively) for at risk groups. This could be more effective than a vaccine to prime the immune system. Does anyone know how we would get approval? Could a hospital stage approval then be used earlier/preventatively? Or would it be a further trial? Clearly the priority here is to stop people dying, but after that this drug could get us out of this whole mess, with a quick puff on an inhaler (think the brown inhaler for asthmatics).
A simple question: following a successful P3 trial for covid would it be a case of starting another P3 trial for all the other illnesses this could potentially treat i.e COPD & other viruses. Or at least for the latter could this P3 trial be enough for broader anti viral use?
Thats how I see it Doc.
Yes if docs know it’s savings lives who’s going to prescribe the placebo? I think this is all going to go quite quick
Al,
What do you see different in these two statements.
"Synairgen's Phase II trial in COVID-19 patients (SG016) will be a double-blind, placebo-controlled trial. "
"Synairgen intends to commence a Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients, named SG018, with an anticipated start date during Q4 2020".
Says to me it's not double blinded. Should be clearly stated if it is. The FDA have advised what is required and ticked off the protocol. They already have 'gold standard' data from the phase 2. If the ratios of death's in the placebo vs SNG001 group continued the phase 3 then there would be another 30 odd people dying for no reason.
There is no confirmation that it isn’t double blinded. Blinding is a gold standard in P3 trails. Which makes the results much more reliable than without. Especially when we talk about 20 countries participating and the final results need to be verified by an authority like FDA or EMA.
And this is a one time opportunity for RM to prove His medicine against a severe form of an inflammatory condition.
When you say "they" I presume you mean the FDA
It isn't double blind as they are desperate to see the results. To be double blinded would be irresponsible
I know there's a 30 day timeline on IND, but that was a timescale for the FDA to get back, after which if you haven't heard from them you can proceed. I'd assume it's possible to go quicker if the FDA prioritise and responds.
out of interest why not double blind - if it was needed last time why isnt it needed this time? great its not as it means at any point things could go mad!
Trying to think of possible timelines here. RM made clear that they are progressing this as fast as possible!
From Joey Diamond's post. First they need IND, then need to wait for 30 days before they can start the trial. Once they have IND they can apply for EUA for people not eligible for the trial.
So, if they anticipate a November start, they expect IND by next week. Hopefully this would be worthy of RNS.
The trial is said to be randomised placebo controlled, but not double blind. This seems to mean the clinicians will know who is getting SNG001 and who is getting placebo. As the trial progresses it will be clear how well it is working and possible to do early analysis and maybe stop the trial for benefit.
So, we certainly may see EUA much earlier than the final P3 results. Maybe even full approval much earlier that final P3 results if stopped for benefit. The need for SNG001 will be more and more desperate as the winter progresses.