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Its not BS. Its a legitimate debate

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ghmm Member Profile ghmm  
Wednesday, October 10, 2012 12:10:23 PM
Re: cl001 post# 234 Post # of 481 
Its not BS. Its a legitimate debate and based on past FDA approvals this would be a first to approve on so little data.

For all the compassion talk one should keep a few things in mind:
1-The company does not even have commercial scale manufacturing in place so even if they wanted to couldn't provide enough drug to everyone.
2-The company could always do a Phase 3 and then some sort of named patient, compassionate use trial.
3-There are about 7000 rare diseases many quite more severe then MD. Believe it or not there are even treatments in development for some of these. Its unfortunate but our regulatory process is slow.

Like I said I have no position so I can argue both sides smile


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