RE:In today's world the paths to FDA Approval are manyThe FDA's paths to oncology drug approval have been opened by the Congressional probe 2 months ago. In March, the FDA’s actions in preventing and responding to the shortages were probed in Congress as the House Committee on Energy and Commerce launched an investigation to uncover if the agency is “effectively using its existing authorities.”
Consequently, in response to this Congressional probe, the FDA has issued their guidance on the "Accelerated Approval" process which is intended to approve and bring novel oncology drugs into the market at a much greater rate than ever before.
Along with ONCY's well designed randomized clinical trial program, these regulatory events have positive impacts on the prospective approval of ONCY's cancer drug pelareorep, now that the Phase 2 Bracelet-1 results are imminently to be announced at ASCO.