On May 12, 2021, we announced that The U.S. Food and Drug Administration (FDA) Office of Neuroscience granted our appeal of the clinical hold on our Phase 1 study after almost two years of clinical hold. …
On May 11, 2021, nearly two years following the initial protocol submission of MT2 to the U.S. Food and Drug Administration (FDA), the FDA Division of Psychiatry removed the partial clinical hold on Study …
On April 26, 2021, MAPS submitted the final administrative step to remove the clinical hold following the successful Formal Dispute Resolution Request (FDRR) which resulted in an Appeal Granted Letter …
On April 16, 2021, nearly two years following the initial protocol submission of MT2 to the U.S. Food and Drug Administration (FDA), the FDA Office of Neuroscience granted MAPS’ Formal Dispute Resolution …
On January 15, 2021, MAPS and FDA held a Type A Formal Dispute Meeting to discuss the continued partial clinical hold on Study MT2. MAPS and counsel presented a summary of the dispute resolution request …
On Clinical Hold for nearly 16 months and unable to resolve this apparent impasse with the FDA, the clinical program was stalled. On December 01, 2020, MAPS, along with legal counsel with expertise in …
On April 30, 2020, the U.S. Food and Drug Administration (FDA) quickly and succinctly denied MAPS’ request for a meeting to resolve the clinical hold issues, citing that the meeting request did not propose …
Unable to resolve these hold issues without substantive feedback from the FDA, MAPS submitted a formal “Type A Meeting Request” on April 20, 2020. This formal meeting request asked the FDA reviewers …
On January 30, 2020, the U.S. Food and Drug Administration (FDA) issued a second Continued Partial Clinical Hold Letter that only briefly restated the issues raised in its prior two hold letters, noting …
MAPS received no response from the U.S. Food and Drug Administration (FDA) to the reconsideration request submitted on October 11, 2020. On December 31, 2019, MAPS provided an additional response with …
On October 11, 2020, MAPS submitted a request for reconsideration on the continued partial clinical hold to the U.S. Food and Drug Administration (FDA), again responding in detail to each outstanding hold …
