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Re: zipjet post# 104280

Wednesday, 09/15/2010 2:31:57 PM

Wednesday, September 15, 2010 2:31:57 PM

Post# of 257302

Clinical trials should run 10 years so we have long term use data.



That's your exeggeration. It's typical being defensive about regulatory requirement. No one said clinical trial need to run 10 years before approval for long term use. You should have at least one or two year data (for those with too many questions raised during trials maybe even longer) before approval for long term use, then have post marketing trial for longer period. Most issues do come from larger and longer term trials.

Forget about new drugs - no company would even try.



I am sure every company wants to run a trial last a few weeks, then get approved for long term use. I worked in one, know how they think. That doesn't mean they are right. Trust me, as long as disease exists, pharma/biotech won't disappear.

jq you have now made one of the worst arguments I have seen this year.



That's not my argument, it's FDA and advisory panel's argument now. In case you are not aware, FDA already revised guideline on diabetes that requires larger and longer cardiovascular outcome trial. More to come for chronical disease. Get used to it.

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