Based on promising results LTR Pharma plans to use this data to support an expedited 505(b)(2) regulatory filing in the United States and subsequent
filings in Australia and other key markets including Europe,Asia,MENA and LATAM.505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
I look foward to hearing that the application has been lodged.
- Relatively lower risk because of previous drug approval
- Lower cost, accelerated development due to fewer studies
- May qualify for three, five or seven years of market exclusivity
Based on promising results LTR Pharma plans to use this data to...
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