Feb. 20 at 3:26 PM
$TLX
My understanding is: they are going to get FDA approval for Pixclara quickly.
"For Pixclara, we have a reasonable idea that it's going to be a rapid review also because it's a single a single issue CRL"
"FDA has granted both orphan drug and fast track designation for Pixclara. Our commercial, medical, and supply chain teams are launch ready. Our expanded access programs serve patients and our customers very well, and they anticipate commercial use of Pixclara"
"For Zircaix, we've completed 2 Type A meetings with the FDA and believe we have full alignment on key resubmission requirements. We are now focused on completing the agreed deliverables and documentation required for the resubmission. With breakthrough therapy designation, supportive ZIRCON-X data and the inclusion in major international guidelines, this remains a top priority for approval and launch this year. This is a really exciting and highly anticipated product."
