Tuesday, September 22, 2020 5:10:55 PM
I will check and get back soon.
Here is teh paper:
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:a4c94d9b-866d-4bc4-962b-f1ed54b43be9
In the meanwhile here is the original Lavin testimony to teh USPTO circa 2012:
Two studies done by Hayashi and Okumura, studies heavily cited by the USPTO to determine overlap, are statistically refuted by the aforementioned doctors. Dr. Lavin concluded:
"That it was unlikely that even one individual in Hayashi or Okumura had an initial baseline triglyceride level above 400 mg/dL."
Okumura states that subjects had TGs between 150 and 500 mg/dL, or in other words, greater than 150 and less than 500 mg/dL. Hayashi states that subjects had TGs "up to 533 mg/dL." Dr. Lavin expects the likelihood of the study containing a subject with a starting TG value of >500mg/dL to be less than 0.015%.
This brings up the statistical analysis performed by Dr. Lavin. In his official declaration (page 43 of my download link), he states the following:
see below
The actual analysis is shown here:
see below
To understand the jumbled table of numbers, one must focus on the "EN>UB" column. In table 1, referring to the Hayashi study, the likelihood of a patient having greater than 450mg/dL TGs is 3%, greater than 500mg/dL .015%, and greater that 550mg/dL .00792%. In table 2, referring to the Okumura study, the likelihood of a patient having greater than 450mg/dL TGs is 0.25%, greater than 500mg/dL .006%, and greater that 550mg/dL .002%.
The conclusion here is that, with a high degree of confidence, there was no actual overlap between Okumura/Hayashi indication patients and Amarin's MARINE patients.
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