RE:RE:Upcoming ...woundedknee wrote: A bit off topic, but i just finished watching an episode from Tucker Carlson Today, interviewing Dr. Aeem Malhotra from the UK. The main theme of his talk is why the covid vacinnes are dangerous and should not be taken. But there was one bit of info he revealed that I did not know and that is that the FDA receives 60% of its funding from Big Pharma. Seems like a conflict of interest to me and also do you suppose they (Big Pharma) may have had some influence on the downfall of ATE from its original mandate? I mean was the "liver problem" so much different than with some of the other popular over the counter drugs who were approved with the proviso that a disclaimer accompany the approval? And how many other nefarious things continue to go on behind the scenes? Getting right down to it..It's all about greasing the right palms imo. You're staying with this company Mugsy..I'll give you credit for hanging in there. gl
Biggest conflict I've paid attention to w.r.t FDA is the Biogen AD drug and how professionals started quitting FDA one by one after Aduhelm was approved - even after all 10 said "do not pass"
Biogen and FDA certainly looked bad (FDA in Biogen's back pocket) but it didn't go unnoticed. It started a huge review and a major problem for both FDA and Biogen.
Anyway - even passing Aduhelm ended up in Aduhelm's failure ... for good reason.
Too expensive with unknown outcomes.
We have had many discussions about similar fears w.r.t. ATE drug sabotage but I think the scales are quite tipped in our favor and the needed replacement for opioids and reduced NSAID bleeding. Also as mentioned - Stauffer really knows this FDA group and will make inroads ... if ... the product deserves it.
As for the AME findings - liver H2S saturation caused by make vs. free situations we created ... best find ever! Certainly not something to fear, it's something to celebrate.
Better it happened at AME rather than during P3.
Great that it led to redesign and 20 years of IP coverage.
Awsome that the chronic dosing can now break past the theoretical lowest possible dosing of chrystalline structure and head lower with the amorphous solution.
Where this puts us is in a unique and ultra-valuable position that now has multiple opportunities ...
- pre-op
- intra-op
- post-op
- other acute spaces
- chronic
- colon cancer
- FAP
- 346 head-2-head with 352
The beauty isn't just in the accelerated on-set of action - but - it includes a better defined end-of-action as well. That all spells a better method for building control within dosing and regimen design.
Add to that - the drug dosing can come down 2-4 fold the amount we were expecting to use for acute purposes and you are now talking about a much safer approach for acute.
With a final determination on direction and a full commitment to the modified formulation ... we are now going to decide on one of 3 chronic directions (after we finish the acute learing). One of three possible chronic directions seems obvious to me - same thing I was saying on private messaging over a year ago.
-----------------------------------
So - Acute and Chronic are exactly where we want them.
Better and safer than ever before.
Pay me now is the approach (mod. formulation) so that we get paid latter (bigger partnering deals). Absolutely worth it (IMO).
So ... the path for 346 is obvious and it's just a matter of full execution of the 346 realities this company has explored over the past 1.5 years.
All I care about now ... is ... IBD
All eyes on this initial design as it will grow from all historical learning at ATE.
Just look at the new 343 to see how design has already progressed.
I also think 343 will sit in the wings to be used in conjunction with IBD as we transition to additional Autoimmune Diseases down the road. The building blocks are coming together but no one said it was going to be easy. No free rides and no simple learning.
Anyway,
All I'm saying is ... be carfeful what you call a mistake, a design issue or even sabatoge. All possible but also look at it from the perspective of new science in need of new technology and an ability to learn from our findings going forward. We are dealing with such small amounts of H2S or H2S2 ro H2S3 or H2S5 that we really need technology to keep pace with the speed we'd like to move with the science. It's all coming together and the glue that allows for this ... is called cash-in-the-bank.
The cash alllows us to go directly to specialist to help us solve complex problems - that's what you want in this business (if you're tiny).
If it were easy - it wouldn't be called drug development.
And if it were easy - it would already be making people wealthy.
Just enjoy the ride as some of the stuff we're about to see is hopefully going to be quite remarkable in the newest fields of gaseous mediation.
: )