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Thursday, June 13, 2019 9:16:45 AM
PS Targeting and cumulative IP, and remember the CTO Confidential Treatment Order that does not go public till 2021 where some details of that Oncologie IP transfer were not fully disclosed
How many CTOs exist ...?
Confidential Treatment Orders that are sealing up the biomarker records have not been published or made public yet it seems since Shelley Fussey did mention the patent filing and nothing went public ..yet
By: Eb0783 10-13-16 #275973
ASM attendees - roughly 40. 20 of us being shareholders.
FU/275979(re: Garnick?): He was a very valuable asset in the meeting.
FU/276020: From the ASM: King said (in answer to a question about B2GP1 stability, a la GJH) that B2GP1 is “relatively stable” among the patients and, although not as much is known about it compared to other proteins, there probably is no more than a +/-10% variation in a given patient.
Dr Garnick said that B2GP1 is only one (and maybe not the most important) of a number of biomarkers and they will have a number of them creating a profile. Lytle said the $$ spend on Sunrise will be finished by around end of calendar year. My take on these two statements is that they will have the analysis done and the biomarker profile will be complete. imo
Garnick shared a story about an early biomarker at Genentech with us that very few people know. Herceptin failed its first trials but one scientist identified the HER2 mutation and saw how many with HER2 lived longer. So they ran another trial which also failed. Garnick and his peers didn't believe in it but one other guy, identified a biomarker that corrolated with the ones who lived, and talked them into spending another $60mm on one more trial. Since then Herceptin has save 1000's of lives and earned $Billions of dollars. He believes in the value of biomarkers and he has been driving it for us.
As to my question of filing the BLA with what we have, [sorry CP, I did agree with your view) Dr Garnick point blank said our data is “not fileable.” We have now proof of concept and need now another trial, even a small phase II, to validate. Keep in mind however that means a smaller trial and with biomarkers involved it could be shorter than we imagine. imo
On a sidebar with just Shelley and I, Shelly Fussey said they have filed a detailed provisional patent on the Biomarkers which sets the filed date, keep it from being published/shared, and allows inexpensive additions/updates for a number of months (forget if it was 6, 9, or 12). Basically, we the public, and their competitors, will not be able to access it for 18mos. It also adds another year to the patent protection that way.
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