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   Biotech / MedicalIncyte (INCY)


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To: scaram(o)uche who wrote (3175)4/24/2018 11:56:50 AM
From: Miljenko Zuanic
   of 3202
 
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: Miljenko Zuanic who wrote (3176)4/24/2018 12:02:24 PM
From: scaram(o)uche
   of 3202
 
>> Hope NEW FDA will be more open for suggestions!!? <<

How could any FDA be more liberal than the Gottlieb FDA?

You'd like 4 mg. approved, with black box? OK, my view.

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To: scaram(o)uche who wrote (3177)4/24/2018 12:30:53 PM
From: Miljenko Zuanic
   of 3202
 
<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: Miljenko Zuanic who wrote (3178)4/24/2018 1:11:12 PM
From: tuck
   of 3202
 
believe that Epa is not dead
Which remaining combos(s) are of interest?

Edit: This P1 with a surviving vaccine looks interesting, and reads out in the next few months.

Study of DPX-Survivac Vaccine Therapy and Epacadostat in Patients With Recurrent Ovarian Cancer

Partial rationale: Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients

TIA & Cheers, Tuck

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To: tuck who wrote (3179)4/24/2018 1:52:41 PM
From: Miljenko Zuanic
   of 3202
 
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
   of 3202
 
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
   of 3202
 
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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To: Miljenko Zuanic who wrote (3182)4/24/2018 3:14:03 PM
From: scaram(o)uche
   of 3202
 
>> now playing with gains <<

Cool. House money, nothing feels better.

My portfolio has been hit HARD, post-epa. Could imagine a few shareholders bumping into margin issues. Loaded up at 3.90, praying seller is finished.

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To: scaram(o)uche who wrote (3169)4/24/2018 4:45:02 PM
From: scaram(o)uche
   of 3202
 
OT, again

>> Look at the daily chart for qure and once versus that for sgmo <<

And sgmo goes for $200m offering of common. Guess that could explain why it's come back so hard, BAML, J.P. Morgan and Cowen lubed. Strange time to get greedy. In the last month..... qure up 20%, once up 12%, sgmo down 21%.

There HAS to be perspective out there that I don't have. Anybody????? TIA.

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From: scaram(o)uche5/4/2018 11:22:37 AM
   of 3202
 
cool..... bloodjournal.org

>> Topical ruxolitinib, unlike corticosteroids, protects Lgr5+ skin stem cells and maintains skin homeostasis in skin GVHD <<

(pointer from Oscar Lahoud)

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