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To: ghmm who wrote (349)3/15/2011 7:27:20 PM
From: rkrw
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Approval with just a single arm p2 would seem to be quite a long shot. Slim to none.

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To: rkrw who wrote (350)3/15/2011 7:38:17 PM
From: ghmm
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I agree but am hoping to be wrong :-). I don't do a lot of investing in oncology companies so perhaps others may know but could only think of Gleevec approved with a single arm Phase 2.

Here is a link to the ASCO presentation of the 102 in ovarian cancer for anyone interested.
nektar.com 

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To: ghmm who wrote (349)3/16/2011 8:20:42 AM
From: idos
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NKTR did say (after meeting with the FDA in Feb), it is planing to start a randomized phase III trial in refractory ovarian cancer next year, after the expanded phase II trial data are out. Think they don't expect that phase II will be enough.

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To: idos who wrote (352)3/16/2011 9:27:42 AM
From: ghmm
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The official line is that even if they get accelerated approval would need the Phase 3 for full approval. I don't think they are over promising their shot at at accelerated approval. What I am more wondering is if they will need the full Phase 2 data before even starting the Phase 3 which would mean the Phase 3 wouldn't start till 2H '12 (if not later).

The expansion of the Phase 2 study is what has me puzzled. If they really have little to no chance why delay things by expanding the Phase 2? At the Cowen conference Robin said that 125 patients are being added and the results would be pushed back about 4 months (from original end of 11 target).

I was curious if they chance is 0 or something slightly higher :-) so was curious on how the data may compare with what may be expected in that patient population (the company says expected overall survival is about 8 months but I'd like to see some studies).

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To: ghmm who wrote (353)3/16/2011 9:35:16 AM
From: rkrw
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They don't need to wait until full P2 data to begin.

Interesting on the 125 patient expansion, that's not trivial.

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To: ghmm who wrote (353)3/16/2011 11:44:21 AM
From: idos
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They did say that phase III will start in 1H '12 so not waiting for full phase II data. Has Robin said if patients in the expanded trial are Doxil pre-treated and get the q21d regimen? If so, I think they want more data on the better responders and regimen to take forward to phase III.

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To: idos who wrote (355)3/16/2011 1:21:48 PM
From: ghmm
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Yes I believe all the additional patients will have had Doxil. I didn't recall hearing the company say if it would be q14d or q21d. I took it for granted it would be q21d based on a bit lower toxicity especially after hearing the doc in the Breast Cancer presentation suggest that dosing may be better in that indication.

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To: ghmm who wrote (356)1/9/2012 2:38:32 PM
From: Arthur Radley
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Major FDA decisions coming up in March----

3/26 is date for FDA action on the (MAPP) NDA

3/27 is date for FDA action on the (AFFY) NDA

Completed filling my position on (AFFY) today when it broke below the $7.00 point.

Would be nice to see both drugs approved--fingers are crossed.

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To: Arthur Radley who wrote (357)1/20/2012 12:17:41 PM
From: Arthur Radley
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bizjournals.com 

Nice feature story in SF Bizjournal----compelling story with broad pipeline.

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From: Arthur Radley2/13/2012 4:09:49 PM
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In the last few day the 13-G filings have been huge for (NKTR). The following firms have filed announcing their position in the stock:
Healthcor
Blackrock
PrimeCap Management
Biotechnology Value
Oppenheimer

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