ADDED
Raising additional funds through debt financings may involve restrictive covenants and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights; Our business is highly dependent on the success of roluperidone, as well as any other potential future product candidates.
If we are unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, roluperidone or any other potential future product candidates, or if we experience delays in doing so, our business will be materially harmed; We cannot give any assurance that any of our product candidates will receive regulatory approval in a timely manner or at all.
Food and Drug Administration ( FDA ) and the results of clinical trials conducted at sites in the U.S.
Our lead product candidate, roluperidone, is in development for the treatment of negative symptoms in patients diagnosed with schizophrenia.
In August 2022, we submitted a New Drug Application ( NDA ) with the FDA for roluperidone for the treatment of negative symptoms in schizophrenia.
Subsequent to the CRL, we have had multiple interactions with the FDA to confirm the design of an additional Phase 3 confirmatory clinical trial to address the deficiencies cited in the CRL and resubmit the NDA.
As with the completed Phase 2b (C03) and Phase 3 (C07) clinical trials of roluperidone, the new Phase 3 confirmatory trial, which we refer to as the C19 trial, will include patients diagnosed with schizophrenia who present with stable impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial.
We agreed with the FDA that best efforts will be made to secure 25-30% of patients from the United States, subject to competitive recruitment.
The FDA confirmed that roluperidone can be studied in monotherapy where patients will receive a double-blinded single daily 64 mg dose of roluperidone or placebo.
The FDA advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks, in patients treated in monotherapy with roluperidone, placebo or antipsychotics.
REMOVED
Raising additional funds through debt financings may involve restrictive covenants and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights; Changes in estimates regarding fair value of intangible assets may result in an adverse impact on our results of operations; We cannot give any assurance that any of our product candidates will receive regulatory approval in a timely manner or at all.
may not be accepted by the FDA and the results of clinical trials conducted at sites in the U.S.
Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to administrative sanctions or penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products; 3 The regulatory pathway for our product candidate, MIN-301, has not yet been determined.
Leveraging our scientific insights and clinical experience, we have acquired or in-licensed compounds that we believe have innovative mechanisms of actions and therapeutic profiles that potentially address the unmet needs of patients with these diseases.
We are developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson s disease.
In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson Johnson ( Janssen ), for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder ( MDD ).
In June 2020, we exercised our right to opt out of our agreement with Janssen for the Phase 3 development of seltorexant and as a result, we were entitled to collect royalties in the mid-single digits on potential future worldwide sales of seltorexant in certain indications, with no further financial obligations to Janssen.
In August 2022, we submitted a New Drug Application ( NDA ) with the U.S.
Food and Drug Administration ( FDA ) for our lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia.
Since receiving the CRL, we have continued to have interactions with the FDA with the goal of addressing the questions raised in the CRL.