My Raging Bull

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psea
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16
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2013-04-06
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psea 2013-08-21 01:54
MannKind Corp New Forum
I've just started a new forum with more forum features. Feel free to join us here:

http://mannkind.freeforums.net/

It's free.
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psea 2013-05-09 16:08
MannKind Corp Q1'13 Earnings Call Notes
Q1'13 Earnings Call Notes


- $125.4mil available on LOC
- ’13 forecasted expenses higher than ‘12
- Fund operations into 4th qtr using avail cash and LOC
- Studies to be completed in May/June
- Only 8 remain in Affinity 1; treatment phase completed
- Only 91 remain in Affinity 2; treatment phase to be completed 5/13
- FDA Agmt w/ FDA to allow expeditious resubmission
- Data to be released in mid-Aug; central to partnership discussions
- Resubmission Late Sept early Oct
- Q&A:
o New suitors have entered the partnership discussion
o Drop out rate tracking slightly higher than planned. Not an issue due to over enrollment
o Pulmonary Safety Study (134 MOPD) – difficult to recruit, focused on label discussion
o Don’t expect cash resources to effect partnership discussions
o Agency has not asked for long term pulmonary safety data. Past trials identified an FEV of 1.01
o Two reviews of forced titration efforts evidenced good adherence to study protocols
o Right to Co-promote in N.A. mkt will be retained by MNKD but haven’t considered execution of this (bringing in the sales force); depends on partner’s capabilities
o After U.S. submission, will turn to EU submission
o Likely to issue PR’s upon completion of trials.
New Forum
Updated 2013-08-21 01:54 by  psea
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Q1'13 Earnings Call Notes
Updated 2013-05-09 16:08 by  psea
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ATM ....hmmmm
Updated 2013-04-26 17:19 by  psea
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