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BTH

12/05/13 9:32 PM

#170849 RE: nuere #170841

Lets spend the next 72 hours arguing if these are real responses or not, lol.

GERN
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iwfal

12/06/13 12:47 AM

#170851 RE: nuere #170841

GERN - Just to set up the conversation once more explicit data is released (hopefully). I.e. not interested trying to parse the latest PRs - but setting up the metrics to evaluate the future data will shorten the argument in a few days:

Among the 22, five patients achieved complete or partial remissions, including reversal of bone marrow fibrosis in four of the five patients. Two of the five patients with complete or partial remission have also experienced complete molecular remissions



If, as Scarlett telegraphed, many of the patients have no spleen they are also likely to have no constitutional symptoms (removing the spleen resolves a high percentage of constitutional symptoms). So Complete Response can be obtained without clinical response assess-able. (It is a neat trick if you want to talk only the markers that matter to you.)

So given that:

1) I give as a dividing line: the data release has no mention of any patients having a spleen response that would qualify as a "CR" clinical response - or if data on spleen clinical response is given in the release then the number mentioned is meaningfully less than the number of CRs claimed (i.e. many/most/all of the CRs are CRs without the clinical response of the number 1/2 symptoms of MF because they are not assess-able)

2) I give as a dividing line: for the patients with a spleen and enlargement they either do not discuss the percent response - or, if they do discuss it, it is meaningfully less good than the response rates seen with Jakafi.

BTW - GERN picked a good partner with Tefferi. ;-)

BTW2 - If, in fact, imetelstat does not create much clinical response then I would suggest it would be best if GERN and Tefferi are straight this - e.g. 'hey, this drug will have to be either given with Jakafi in some way. Or with a splenectomy.' (Note that a splenectomy in this population is fairly hazardous with about a 10 pct mortality - at least in the latest data I found circa 2000.) The drug almost certainly has a place - but avoiding looking straight at it will just result in unnecessary (and somewhat unpredictable) bumps in the road (i.e. delayed schedule and worse label and ...).