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Tuesday, April 26, 2005 12:49:19 AM
More on Monday’s ATryn news:
[From the Yahoo GTCB board, which is rapidly sinking in quality.]
>>
Re: work HORSES --
by: DewDiligence
04/26/05 12:20 am
Msg: 19005 of 19005
>>DEW, did you have something to DEW with this - 'work DILIGENTLY'
<<
LOL, Floblu.
Seriously, I think the wording in Monday’s PR was carefully chosen. Let’s look at Dr. Cox’s quote one more time:
“…we are pleased that the EMEA has granted us this extension to complete our response to all outstanding issues….This provides us with the opportunity to bring our MAA to a successful conclusion and we will be continuing to work diligently towards this goal.”
In sharp contrast to GTC’s prior ATryn PR’s, which were wishy-washy and open-ended, the above quote is firm and clear: if GTC satisfactorily answers the outstanding questions, the Q&A iterations will come to an end.
To use sports terminology, this is now GTC’s game to lose. The EMEA has presumably told GTC that they are ready and willing to approve ATryn unless GTC somehow screws up the answers to the last batch of questions. Compared to what we knew as recently as last week, the execution risk for ATryn has been significantly reduced. Regards, Dew
Posted as a reply to: Msg 18986 by floblu14
<<
[From the Yahoo GTCB board, which is rapidly sinking in quality.]
>>
Re: work HORSES --
by: DewDiligence
04/26/05 12:20 am
Msg: 19005 of 19005
>>DEW, did you have something to DEW with this - 'work DILIGENTLY'
<< LOL, Floblu.
Seriously, I think the wording in Monday’s PR was carefully chosen. Let’s look at Dr. Cox’s quote one more time:
“…we are pleased that the EMEA has granted us this extension to complete our response to all outstanding issues….This provides us with the opportunity to bring our MAA to a successful conclusion and we will be continuing to work diligently towards this goal.”
In sharp contrast to GTC’s prior ATryn PR’s, which were wishy-washy and open-ended, the above quote is firm and clear: if GTC satisfactorily answers the outstanding questions, the Q&A iterations will come to an end.
To use sports terminology, this is now GTC’s game to lose. The EMEA has presumably told GTC that they are ready and willing to approve ATryn unless GTC somehow screws up the answers to the last batch of questions. Compared to what we knew as recently as last week, the execution risk for ATryn has been significantly reduced. Regards, Dew
Posted as a reply to: Msg 18986 by floblu14
<<
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