Successful Outcome of FDA Type C Meeting Request for HARMONIC Ph 2 Trial of LP-300 in Never-Smokers with NSCLC Announced
“In our view, this successful Type C interaction with the FDA is a meaningful de-risking milestone for the LP-300 program and for the HARMONIC™ trial. The FDA’s response to our proposed amendments supports our strategy to focus HARMONIC™ on the EGFR exon 21 L858R-mutant never-smoker population, where emerging data suggest LP-300 may offer meaningful differentiated benefit when added to standard chemotherapy following TKI failure.”, said Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc.
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