I enjoy your cut to the chase observations, at lea
Post# of 154874
(Total Views: 449)
Posted On: 01/02/2021 5:12:29 PM
I enjoy your cut to the chase observations, at least in the medical community we add to your analogy everyone has one but we don't want to hear from them....
I probably should not have introduced that link as "an opinion piece" he has hard data on mortality studies and reviews the specific studies only mention very few become statically significance especially when Type 1 errors are factored in (combined false positive and false negative) and thereby the rejection of the null hypothesis. He does not state they are to be abandoned altogether, they often shed light on the SECONDARY endpoint. I bring this up in the event CD12 does not achieve overwhelming data, that DOES not mean that it does not decrease mortality.
The article simply states that if all cause mortality is not significant, drill down on secondary endpoints, the drug should not be abandoned before that analysis. Of course reproducibility in non-company sponsored trials is the gold standard to create "Evidence Based Medicine" which will market the drug to providers without spending a dime.
All positive news for us, obviously time will tell.
I also think this applies to us: Oncoimmune CD24FC trial was completed in September with very promising results. They stated they would wait for submitting to the FDA until peer reviewed publications were made. Then they were bought by Merck still not approved, yet the government signed a $350,000,000 contract. Still not approved. Merck announced a major capital investment in repurposing of their manufacturing platform. I surmise the FDA is waiting for evidence of a reliable supply chain.
I probably should not have introduced that link as "an opinion piece" he has hard data on mortality studies and reviews the specific studies only mention very few become statically significance especially when Type 1 errors are factored in (combined false positive and false negative) and thereby the rejection of the null hypothesis. He does not state they are to be abandoned altogether, they often shed light on the SECONDARY endpoint. I bring this up in the event CD12 does not achieve overwhelming data, that DOES not mean that it does not decrease mortality.
The article simply states that if all cause mortality is not significant, drill down on secondary endpoints, the drug should not be abandoned before that analysis. Of course reproducibility in non-company sponsored trials is the gold standard to create "Evidence Based Medicine" which will market the drug to providers without spending a dime.
All positive news for us, obviously time will tell.
I also think this applies to us: Oncoimmune CD24FC trial was completed in September with very promising results. They stated they would wait for submitting to the FDA until peer reviewed publications were made. Then they were bought by Merck still not approved, yet the government signed a $350,000,000 contract. Still not approved. Merck announced a major capital investment in repurposing of their manufacturing platform. I surmise the FDA is waiting for evidence of a reliable supply chain.
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