Iovance Biotherapeutics Inc at Jefferies Healthcare Conference Transcript
Good morning, everyone. Thank you for joining us on another great session here at the Jefferies Healthcare Conference. I'm Michael Yee, senior biotechnology analyst at Jefferies. And very happy to have on the stage with us members of the Iovance management team, Interim CEO, Fred Vogt, as well as the COO, Igor Bilinsky. Importantly, they're joining us now at a time when the BLA was recently accepted by the FDA with the priority review. And I believe there's a PDUFA date. as well, formally for November. and with no planned AdCom. So should be straightaway steady sailing towards an approval.
And maybe that would be a good start to offer Fred an opportunity to maybe talk a little bit about the journey this year, right, now that the BLA is on file. How you're feeling about this year, both from a regulatory review standpoint and preparing for approval and commercialization of this new melanoma drug?
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