Post by
MrMugsy on Aug 20, 2021 9:17am
Let's start fresh here guys ...
You can see from the reduced garbage on this site ... that the trash man came and cleaned the streets. Let's get back to discussions. Sure we'll disagree but let's get back to what this place was before all the panic.
1. review data by Oct 4 and decide on path forward.
2. if data shows a potential to reduce dose then apply for AME (30 days - by mid-November)
3. AME at 75, 50, 25, 10, 5 mg (done by March) while also working on fast-track for 352 replacement ... multiple paths for this drug.
4. Phase 2 (60-80 people)
5. Phase 3 ... hopefully starting before 2022 is over ... that would be nice ! Hopefully P3 is reduced from a P2/3 as dose ranging shouldn't be required (just an assumption on my part).
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During this time, progress on Respiratory/COVID, FAP and Ulcerative Colitis.
I'm guessing our new IBD drug with its "remarkable anti-inflammatory properties" will be used here.
Would be nice to announce a an initial path for Alzheimer's/Parkinson's as well. If Biogen was any indication of what the market was looking for ... they pumped up Biogen's value on the FDA greenlight by $20B. Sure it came down since but that's only because investors realized the Biogen's path wasn't all that great. I'm sure we can do so much better.
EOM
Comment by
MasterAlgae on Aug 20, 2021 9:24am
The science needs to be supported by a new WOMAC study first to see if the pain reduction is still significent at lower doses. Pain reduction might not be significent at 75 mg. What is the lowest amount of H2S that provides significent pain reduction in one pill a day? If 75 does not privide significent pain reduction for 24 hours then no point in going forward with the other tests is there?
Comment by
MasterAlgae on Aug 20, 2021 9:38am
Actually I'm wrong. WOMAC does not need to be redone. It is not about pain relief it is about GI safety. (Significant is with an a not ane).