To: tuck who wrote (3123) | 4/23/2018 5:03:16 PM | From: tuck | | | Now the FDA AdCom vote. Two doses. 10-5 in favor of 2mg, and 10-5 against the 4mg on the risk-benefit metric. If approved, can the 2 mg dose make commercial inroads on competing products from PFE and ABBV?
Cheers, Tuck |
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To: scaram(o)uche who wrote (3175) | 4/24/2018 11:56:50 AM | From: Miljenko Zuanic | | | Not clear is it JAK2 related, not related to platelets count (which actually decrease, not increase), so search for an answer not condemn drug in start. No trial can be executed to CONFIRM safety signal (not ETHICAL). So, THE ONLY WAY is REAL LIFE EXPERIENCE (controlled with BOX warning and proper management). Hope NEW FDA will be more open for suggestions!!??
Approval without option to increase dose, IF needed, is worthless. Some panel members had open mind, but they were in minority. |
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To: scaram(o)uche who wrote (3177) | 4/24/2018 12:30:53 PM | From: Miljenko Zuanic | | | <How could any FDA be more liberal than the Gottlieb FDA?>
They (reviewers) had a chance to change how they should review revised application, but they did not. They kept old (from CRL) format focusing on 4 mg safety, not overall modality of approval, that LLY asked. 2 mg for overall population, refractory/failed methox, and bumping to 4mg for those who need MORE. FDA had a chance to dictate scope of discussion, but they did not!
That is my problem with FDA. I do not favor/disfavor with their decision, but how they come to conclusion is "problematic"!
I own INCY (after 301 fiasko, believe that Epa is not dead), and Bidi does not make thing any easy. |
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To: tuck who wrote (3179) | 4/24/2018 1:52:41 PM | From: Miljenko Zuanic | | | Because of the good safety, I would bump dose to 300mg/day and continue to combine with anti-PD1 (overall IO), and add selected chemo (selected to cancer type). Head & Neck, maybe CRC and Ovarian, Nivo still may be good choice!??
Combination with vaccines, but delivered intra-tumoral. ASCO may bring some more p2-chombo data from ECHO-204! |
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To: Miljenko Zuanic who wrote (3178) | 4/24/2018 2:45:27 PM | From: scaram(o)uche | | | So you bought after the disaster, and believe Epa still lives? Interesting, hope it works for you.
I haven't owned shares for ages. I had no interest in a "universal lever on the immune response", believing that a non-specific lean on Tregs and dendritic cells wouldn't deliver. There are many agents that just gently nudge the balance between effectors and Tregs, still don't understand why IDO became the realm to bet on.
Disaster in I/O space doesn't hold water, my view. Why IDO's issues float into TLR9, sting or GITR (etc.) space escapes me. Wishing you luck, as any success would lead to rather pronounced profit.
off topic.... forced selling in VKTX? |
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To: scaram(o)uche who wrote (3181) | 4/24/2018 3:06:54 PM | From: Miljenko Zuanic | | | RE:VKTX "force selling"---> it may be!? Secondary @5 was OK, nothing change,...so, I have no idea what is going on?
Data in p2 may be bit late (many sites opt to discontinue), the Qs are would it perform? I hope. As I mentioned early, I recover initial investment, now playing with gains. |
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