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Sadoldgit - thank you for the useful explanation.
Krone, you can have a look at the following :- https://pacificbiolabs.com/maximum-tolerated-dose-mtd-an-effective-preclinical-dose-determination-strategy
Regards
Oh but the suspense is so exciting. Only Sar can keep you on the edge like this even more so now that so much tyk2 and jak info. is being busted out from the medical community and some majors- oh and we're about to go into a second phase of covid19 so the need is going to get even more urgent. No tox, no mtd, orally administrable and only one left to licence in the world with patents already in place and extra's being applied for with strong basis for granting - so exciting you almost wet yourself waiting.
I think it would be good if SAR would advise that an application has in fact been submitted, keeping us shareholders informed. That way we would know where we are up to. Even if it was turned down, it's better for us to know what the BOD are doing rather than us constantly guessing.
re MTD
https://www.fda.gov/media/71542/download
my take on the above is that you can use a dose that may be 10 times to 50 times what is expected to be therapeutic in trials without an MTD. It looks like intended to prevent animals from unnecessary harm in preclinical. Not my area of expertise though.
Labman - the March 2020 half-year report noted:
SDC-1801 has demonstrated excellent tolerability in toxicology studies in rodents and is undergoing studies to complete the dose-finding and longer-term toxicology studies, which would form part of the regulatory documentation needed to apply to begin human trials.
In the follow-up conference call TM stated that they haven't yet reached the MTD and indicated that "this was a nice problem to have'...
Fadec/Thoth - could the drug be trialed without having previously established the MTD?
Krone, apologies if im barking up the wrong tree here but i understood that we had already reached a therapeutic dose . If so, then could this drug not be trialed or used up to the current tolerated dosage level without yet knowing the MTD?.
cheers
Hi Fadec totally agree that the main focus should be on finalising preclinical, but the 25th of June quoted data was full on with Covid-19 so beilive no reason to disbelive wouldnt be surprised if applications are already submitted and Sar will RNS on successful funding.
https://quoteddata.com/research/sareum-holdings-potential-strategy-covid19/
"Sareum intends to make grant applications to explore the activity of SDC-1801 in COVID-19"
This is probably a side show Damion, it raised the profile of the company and then there was a placing, as identified by many here, and this was mentioned 4 months ago in the RNS, also another sign is that there are no prominent other Tyk2 assets that have not been selected against covid19 and currently in human trials as JAK1 signaling is suggested to be more advantageous in inhibiting and dampening the immune system for covid19 so with the time it’s taking I think there might not be enough supporting information for the application!
26 March 2020
Half year report!
The Company intends to investigate grant funding opportunities to assess the potential use of its inhibitors to address this threat to global public health.
Covid Grants 4 - 6 weeks from application to approval ? could be news on funding sooner rather than later
everone is looking at JAKs for Covid-19. Novartis latest. Right place right time for once :)
https://www.cphi-online.com/arctoris-supports-global-research-efforts-to-find-news084106.html
Stoney - Re Aurora - I'd love to know 'who found who'. I suspect they found SAR!
Krone - We must be close to establishing MTD. Trading update?
RMM - So the key question would seem to be how long will it take to establish the MTD?
Hi RMM
Good summary
We are kind of already in the race with our FLT3.....hoping for good news soon from our secretive partner and them getting compound working and they agree to push it forward.
GLA
Stoney - The Chinese are most definitely on the prowl and have been for some time. I would be very surprised if SAR isn't on someone's radar (forget the conspiracy theories about NDA's etc, conversations will have taken place). What I suspect they want (all pharma's not just the Chinese) is a tipping point in terms of data and that means sorting out a few things like MTD. Interestingly Moderna published the trials results of their Covid 19 vaccine yesterday and it makes interesting reading. Their headline is that its safe and produced an antibodies increase. At the lowest dose 50% of the sample reported mild adverse events. At the middle dose 100% of the sample reported mild adverse events. At the highest dosage 100% reported adverse events including one participant with a fever of 103.79 (that's borderline dangerous). According to Moderna the vaccine is 'safe'. Now put 1801/2 in context and we've yet to find a MTD. Now that is safe! Are you watching big Pharma? We might have something you want...... GLA
Hi All
Interesting read......
https://asiatimes.com/2020/07/china-aims-to-lead-the-world-in-biotech-says-expert/