RE:RE:RE:Did you think 5x Liver Enzymes is Serious?This company is super defensive and ultra-low risk given Dan's legal background and fear mongering. That's why he needs to go asap imho - his response to anything out of the ordinary is predictable and protects his own interests above all. Cover himself right? Screw the company.
To your points:
1. 5x increase in liver enzymes in 3 participants when baseline expectation is some degree of liver enzyme elevation in 3-4 people is not concerning when we know the effect is not dose-dependent (meaning increasing the dose will not increase liver enzymes). If it was dose-dependent, then you're right, but it's clearly NOT dose-dependent. Also your opinion of the importance of the magnitude i.e. 3x elevated vs 5x elevated is completely is
incorrect in this range. Cannot draw any conclusions about hydrogen sulfide pipeline from 42 participant AME study especially when tonnes of research proves otherwise. Even in Phase 3 study, 5-10% of participants will have elevated liver enzymes, and this is always going to be the case with NSAIDS (don't forget the parent moeity of Otenaproxesul is Naproxen).
2. Optimal dosing delay, yes, this is known, this is why after 2b read out, intentionally results "flopped". Optimal dosing does not change because of 3 people with abnormal liver enzymes at 100 mg. Were liver enzymes abnormally high at 75 mg? 150 mg? 200 mg? 250 mg? No??? Then what's the optimal dose? The optimal dose is the lowest effective dose where safety is comparable to standard NSAIDS. Yes it will be a delay but looks like 75 mg to 150 mg is the optimal dose particularly when this confounder is accounted for.
3. Formulation, if the same method for formulation was used, then there should not be a concern. This is something only the company would know in the formulation of 75 mg and 100 mg vs. 150 mg, 200 mg, and 250 mg. An error in formulation would presumuably been seen at 75 mg and 100 mg, but since we did
not see that, there's clearly something else going on.
Before blaming the dose or the formulation, let's blame the participants because with certainty if they did some alcohol, cannabis, drugs, tylenol, additional NSAIDS, or had an infection, COVID or non-COVID, this is the MOST likely reason for the liver enzyme increase. Let's not kid ourselves, this a multi-billion dollar drug and big pharma sabotage is very real, especially if the participants intentionally broke protocols.
I hope that helps. GLTA.
MasterAlgae wrote: It is incredibly serious. It is 500% higher than normal. Even if it is alcohol related that is a major danger for this arthritis drug.
The entire pipeline is all hydrogen sulphide...
The press release said that further research is warranted on the formulation of the drug. That's Serious.
"these findings indicate that further research is warranted with respect to both the optimal dose range and potential improvements to the formulation. These efforts will impact the plan for the Phase III program."
It absolutely impacts their position with partnering in a serious negative way...
It is not inconceivable that Antibe is circling the drain.
RalphRalph wrote: It's serious in the sense that it's going to delay Phase 3 and potentially alter their dosing strategy. It also undoubtedly has a negative impact on investor confidence, and certainly doesn't help the company negotiating position with big Pharma. It also creates a significant amount of uncertainty about numerous aspects of the path forward mstrmnd wrote: It's not...especially when higher doses are safe, therefore it's not dose-dependent
If up to 10% of patients on NSAIDS can have liver enzyme elevation normally, then we would expect at least 4 participants from the 42 person AME to have some degree of liver enzyme elevation...
Once everyone starts selling, can't stop irrational behaviour particularly when fear sets in...
New Buyers - Do your own DD - GLTA