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Biotech / Medical Incyte (INCY)

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To: Miljenko Zuanic who wrote (3167)	4/9/2018 3:32:04 PM
From: scaram(o)uche	of 3202

OT >> OT: Nice move in QURE, too! << Look at the daily chart for qure and once versus that for sgmo. Edit et al. having trouble due to fear over pre-existing antibody?

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To: scaram(o)uche who wrote (3169)	4/9/2018 8:31:22 PM
From: Miljenko Zuanic	of 3202

Seems that AAV5 ( AMT-061) has lower pre-existing mAbs titar! They are going strait with dose of 2 x 10^13 gc/kg: clinicaltrials.gov

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To: Miljenko Zuanic who wrote (3170)	4/10/2018 2:02:14 PM
From: scaram(o)uche	of 3202

Ah, OK. Thought the big move was all avxs sentiment. Thanks!

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To: scaram(o)uche who wrote (3171)	4/10/2018 2:12:31 PM
From: Miljenko Zuanic	of 3202

OT: ONCE benefited the most! EOM

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To: tuck who wrote (3123)	4/23/2018 5:03:16 PM
From: tuck	of 3202

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: tuck who wrote (3173)	4/23/2018 5:50:35 PM
From: Miljenko Zuanic	1 Recommendation of 3202

Never hear so much (and so many) incompetent panels of RA "experts"! They do not know what they voted and for what they voted?

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To: Miljenko Zuanic who wrote (3174)	4/24/2018 11:18:53 AM
From: scaram(o)uche	of 3202

Therapeutic window!! Large enough that a panel of FDA-deemed experts said yes! ;-(

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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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