Hi Loose! It's in the 9/30 10k. "Even if our pro
Post# of 72447
Posted On: 12/11/2013 10:53:32 PM
Re: Loose Lips #11729
Hi Loose! It's in the 9/30 10k.
"Even if our product candidate Prurisol receives regulatory approval, commercialization may be adversely affected by regulatory actions requiring a boxed warning.
Even if we receive regulatory approval for our psoriasis product candidate Prurisol, we expect an approval to include a boxed warning regarding possible severe health risks and side effects. Products with boxed warnings are subject to more restrictive regulations than products without such warnings. Boxed restrictions would make it more difficult to market Prurisol." P.24
Trouble with this is new agent with black box will be considered higher risk to prescribers who will look for lower risk answer. By the time prur hits the market - it may have a few new competitors without black box warnings. Those will be prescribed first by the majority of clinicians due to simple safety assessment. Risk vs benefit. The nontoxic will be prescribed before the more toxic. Then, if comparing 2 black-boxed meds for same condition, evidence-based clinician will rx the agent with the most population usage data supporting the script. Not saying it won't be used - just that it is unlikely to be competitive.
"Even if our product candidate Prurisol receives regulatory approval, commercialization may be adversely affected by regulatory actions requiring a boxed warning.
Even if we receive regulatory approval for our psoriasis product candidate Prurisol, we expect an approval to include a boxed warning regarding possible severe health risks and side effects. Products with boxed warnings are subject to more restrictive regulations than products without such warnings. Boxed restrictions would make it more difficult to market Prurisol." P.24
Trouble with this is new agent with black box will be considered higher risk to prescribers who will look for lower risk answer. By the time prur hits the market - it may have a few new competitors without black box warnings. Those will be prescribed first by the majority of clinicians due to simple safety assessment. Risk vs benefit. The nontoxic will be prescribed before the more toxic. Then, if comparing 2 black-boxed meds for same condition, evidence-based clinician will rx the agent with the most population usage data supporting the script. Not saying it won't be used - just that it is unlikely to be competitive.
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