Reminder of possible upcoming catalyst for PI!
$Matinas BioPharma (MTNB.US)$ a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform technology, announces receipt of written feedback from U.S. Food and Drug Administration (FDA) on its proposed revised protocol for a Phase 3 study of MAT2203 in patients with invasive aspergillosis with limited or no treatment options. The preliminary written comments move the Company closer to alignment with FDA on the design of a single Phase 3 registration trial for the approval of MAT2203. At the FDA’s invitation, Matinas is planning a meeting early in the first quarter of 2024 to discuss and finalize the Phase 3 protocol and position MAT2203 to commence Phase 3 as soon as possible thereafter.
“We remain grateful to FDA for the ongoing constructive dialogue around the Phase 3 program for MAT2203 and we believe we share the common goal of positioning MAT2203 for review and approval while minimizing regulatory risk,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “The latest feedback from FDA has moved us closer to agreement, and we believe accepting the FDA’s invitation for a meeting in early 2024 will be the final step in achieving full alignment with FDA.
“Our goal remains to design and implement a feasible and interpretable Phase 3 clinical trial leading to an approval that will meet a significant unmet medical need for patients. We believe that this could lead to a promising commercial opportunity for Matinas. The data generated in our ongoing Expanded Access/Compassionate Use Access program has continued to increase our optimism for our Phase 3 study and its probability of success and has been impactful in our discussions with the FDA,” he added. “We remain engaged in an active partnership process and have updated these parties as we continue to engage with the FDA. Importantly, we believe that achieving complete protocol alignment is not a prerequisite to consummating a potential transaction.”![]()
“We remain grateful to FDA for the ongoing constructive dialogue around the Phase 3 program for MAT2203 and we believe we share the common goal of positioning MAT2203 for review and approval while minimizing regulatory risk,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “The latest feedback from FDA has moved us closer to agreement, and we believe accepting the FDA’s invitation for a meeting in early 2024 will be the final step in achieving full alignment with FDA.
“Our goal remains to design and implement a feasible and interpretable Phase 3 clinical trial leading to an approval that will meet a significant unmet medical need for patients. We believe that this could lead to a promising commercial opportunity for Matinas. The data generated in our ongoing Expanded Access/Compassionate Use Access program has continued to increase our optimism for our Phase 3 study and its probability of success and has been impactful in our discussions with the FDA,” he added. “We remain engaged in an active partnership process and have updated these parties as we continue to engage with the FDA. Importantly, we believe that achieving complete protocol alignment is not a prerequisite to consummating a potential transaction.”
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