Well Managed Care coverage won't fix this!!

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Question: Although the recent news yesterday is unsettling, why is everyone saying it is so negative? There are questions/concerns the FDA wants further clarification on, which hopefully will be addressed next week (the 23rd), but doesn't that happen alot prior to a Drug Approval Date?..................
 



yes correct

the negatives probably coming from big pharma me too prior reps that have never experienced this process especially with orphan status updates and requirements
 



Anonymous said:
Question: Although the recent news yesterday is unsettling, why is everyone saying it is so negative? There are questions/concerns the FDA wants further clarification on, which hopefully will be addressed next week (the 23rd), but doesn't that happen alot prior to a Drug Approval Date?..................
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Yes it is norm, but when the questions are about poor results, then it makes it a press release...hence
 



Anonymous said:
Yes it is norm, but when the questions are about poor results, then it makes it a press release...hence
Click to expand...


Thanks. I agree that there is cause for concern, but I don't understand still why we should be pessimistic that there won't be an approval by 3/28? If you read the press release and also read the Webcast Presentation from CHTP's CEO from yesterdays investor meeting, they talk not so much about efficacy but the pt. population, safety and duration
of trials, and in response much of that may be covered next week to include data from Japan (where the drug has been out for years).

It is an Orphan Disease State, so naturally these concerns are going to come up, correct? Perhaps CHTP is being proactive and open about it in order to answer & alleviate concerns during next weeks panel meeting? I am not an expert, I am just wondering (& hoping)............
 



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