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Biotech / Medical : Coronavirus / COVID-19 Pandemic -- Ignore unavailable to you. Want to Upgrade?


To: Glenn Petersen who wrote (20698)5/6/2022 3:33:41 PM
From: Thomas M.1 Recommendation

Recommended By
Savant

  Respond to of 22867
 
Ed Mills, the senior author of that study:
I actually think it is quite positive. I presented this a couple weeks ago at the NIH Collaboratory Rounds and, if they listened, I advocate that actually, there is a clear signal that IVM works in COVID patients, just that our study didn’t achieve significance.

I really don’t view our study as negative and, also in that talk, you will hear me retract previous statements where I had been previously negative. I think if we had continued randomizing a few hundred more patients, it would have likely been significant.

stevekirsch.substack.com
Tom



To: Glenn Petersen who wrote (20698)10/19/2022 11:04:41 PM
From: Thomas M.1 Recommendation

Recommended By
Stormwatch17

  Respond to of 22867
 
It appears that Together Trial is a fraud. They've been hiding their data for 14 months.

The FDA ain't buying it.
FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic.

prnewswire.com
Last month Eiger gave a hint:
Following a cooperative and extensive pre-EUA information exchange with FDA regarding the Phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency has indicated that it is not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met. FDA has indicated that it will consider any new information and data from the TOGETHER study to support an EUA.

ir.eigerbio.com

The fraud was expected, based on who was backing and promoting the trial, as well as the numerous "tricks" the yengaged in:
  • sneaky trick to underdose patients - ordered them to take Ivermectin without food - reduces uptake by up to 80%
  • drug group administered during deadly Gamma surge, but not the control group
  • changed endpoints after trial was underway
  • advertised as randomized, but apparently not
Tom