Practical Considerations Following Papzimeos' Approval

Pharmaceutical executive: What are the practical considerations now that Papzimeos is approved?

Helen Sabzevari: As mentioned, for papzimeos, we have our own commercial GMP manufacturing on site, which for the past years, has been involved in and producing a commercial material. So we have been anticipating the once we have the approval, which now we do, from FDA, that we have enough commercial material to hit the ground running. And as we speak, we have sufficient doses to address the patients, and our commercial manufacturing continues to obviously produce further amounts, both for usage in us and also for the global usage. So that's the from our manufacturing side, and as we have been building are also commercial capabilities for the past year. And we have our Chief Commercial Officer, Phil tenant, who has been expanding the organization and preparing the organization in the past year, and as we have spoken currently, immediately after approval, our organization has been ready to hit the ground running our MSLs have been already In the field since April, and educating the basically the field, in regard to the disease, as well as in regard to the mechanisms of actions and so on and so forth. And now that we have the full approval or commercial force are out there and interacting with the sites and preparing them for basically enrollment. They are enrolling the patients and the patients receiving the papzimeos. So this is a quite an exciting time, because at this point, this is first time that these patients have an option to receive a treatment that it actually addresses the underlying cause of their disease and with the favorable safety, efficacy and durability of response.