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Re: DR Ryan post# 27094

Tuesday, 09/18/2012 5:35:35 PM

Tuesday, September 18, 2012 5:35:35 PM

Post# of 411414
Not Ph3 which would be for the extended 24 hour Opioids but they only need a couple million for a couple ANDAs and an 505B2 opportunity. All abuse resistant. It is important that we separate these items.

What was previously thought of as Eli 216 is really multiple applications with varying NDA costs.

A brand new drug like a 24 hour Oxycodone would require a full Ph3 efficacy study...

However Bio-equivelency studies for a generic abuse resistant product would be much less.

You can look up the quotes from the CC transcript above.
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