Will the antidepressant get approved

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anonymous

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I have read that one of the components is fast tracked and the FDA would like this product on the market. I also read the studies were not impressive. Does anyone from the company have any real skinny? I have an interview with a manager real soon. Thank you.
 






neither component is fast tracked - they are two generics - buprenorphine and naltrexone

A monthly buprenorphine injectible was fast tracked at another company for Opioid Use Disorder but it was already approved.
 






anonymous said:
neither component is fast tracked - they are two generics - buprenorphine and naltrexone

A monthly buprenorphine injectible was fast tracked at another company for Opioid Use Disorder but it was already approved.
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No that is incorrect Samidorphan is the other part of this drug and IT IS fast tracked. Do a bit of research. Samidorphan has some of the same properties of naltrexone but two different molecules. I kid you not.
 






anonymous said:
No that is incorrect Samidorphan is the other part of this drug and IT IS fast tracked. Do a bit of research. Samidorphan has some of the same properties of naltrexone but two different molecules. I kid you not.
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Actually, you don't know if the approval for the drug is fast tracked yet. You will have to wait until you get a PDUFA date. That will let you know if an expedited review has been granted. I love how morons on this site spew such bull crap or believe they know what's going on when their actual posts show they are actually ignorant fools.
 






anonymous said:
Actually, you don't know if the approval for the drug is fast tracked yet. You will have to wait until you get a PDUFA date. That will let you know if an expedited review has been granted. I love how morons on this site spew such bull crap or believe they know what's going on when their actual posts show they are actually ignorant fools.
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Research dumb ass It is out there.
 






anonymous said:
Actually, you don't know if the approval for the drug is fast tracked yet. You will have to wait until you get a PDUFA date. That will let you know if an expedited review has been granted. I love how morons on this site spew such bull crap or believe they know what's going on when their actual posts show they are actually ignorant fools.
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Nobody knows.
 












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