Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure.
As previously disclosed, Medivation, Inc. has recently concluded that the mechanism of action of MDV9300 (pidilizumab) is not as an inhibitor of PD-1, and work is underway to determine the mechanism of action. Under its investigational new drug application (IND) for MDV9300, Medivation has advised the U.S. Food and Drug Administration (FDA) of this conclusion, and the FDA has placed the IND on partial clinical hold and requested Medivation to revise relevant statements in the related investigator brochure, protocols and informed consent documents. Medivation may not enroll patients into its Phase 2 clinical trial evaluating the safety and efficacy of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma until such statements are revised and the partial clinical hold is removed. Although the Phase 2 clinical trial was initiated in December 2015, no patients have been enrolled to date. Medivation believes the partial clinical hold does not relate to concerns regarding the safety of MDV9300. Medivation plans to submit the requested documents in February 2016. The FDA has 30 days thereafter to notify Medivation if clinical studies with MDV9300 may be resumed. Under the partial clinical hold, patients who are currently receiving MDV9300 through investigator-sponsored trials of MDV9300 that cross-reference Medivation's IND may continue on treatment, but Medivation must inform investigators to update protocols and informed consent documents to state that MDV9300 is not an anti-PD-1 antibody.
In addition, Medivation intends to submit an amendment to the Chemistry, Manufacturing and Controls (CMC) section of its IND for MDV9300 to address certain manufacturing changes. Medivation plans to submit the CMC amendment in the first half of 2016 and intends that patients in its Phase 2 clinical trial will be treated with MDV9300 manufactured in accordance with the amended IND.
The Company has furnished an updated corporate presentation as Exhibit 99.1 to this Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.
Item 9.01. Financial Statements and Exhibits.
Where exactly as this previously disclosed?
Item 7.01. Regulation FD Disclosure.
As previously disclosed, Medivation, Inc. has recently concluded that the mechanism of action of MDV9300 (pidilizumab) is not as an inhibitor of PD-1, and work is underway to determine the mechanism of action. Under its investigational new drug application (IND) for MDV9300, Medivation has advised the U.S. Food and Drug Administration (FDA) of this conclusion, and the FDA has placed the IND on partial clinical hold and requested Medivation to revise relevant statements in the related investigator brochure, protocols and informed consent documents. Medivation may not enroll patients into its Phase 2 clinical trial evaluating the safety and efficacy of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma until such statements are revised and the partial clinical hold is removed. Although the Phase 2 clinical trial was initiated in December 2015, no patients have been enrolled to date. Medivation believes the partial clinical hold does not relate to concerns regarding the safety of MDV9300. Medivation plans to submit the requested documents in February 2016. The FDA has 30 days thereafter to notify Medivation if clinical studies with MDV9300 may be resumed. Under the partial clinical hold, patients who are currently receiving MDV9300 through investigator-sponsored trials of MDV9300 that cross-reference Medivation's IND may continue on treatment, but Medivation must inform investigators to update protocols and informed consent documents to state that MDV9300 is not an anti-PD-1 antibody.
In addition, Medivation intends to submit an amendment to the Chemistry, Manufacturing and Controls (CMC) section of its IND for MDV9300 to address certain manufacturing changes. Medivation plans to submit the CMC amendment in the first half of 2016 and intends that patients in its Phase 2 clinical trial will be treated with MDV9300 manufactured in accordance with the amended IND.
The Company has furnished an updated corporate presentation as Exhibit 99.1 to this Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.
Item 9.01. Financial Statements and Exhibits.
Where exactly as this previously disclosed?