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| Statement |
|---|
| I am very confident that we will be able to address the questions they might have or more in-depth review of some of the topics that you already raised |
| The Phase 2b study was positive and met the primary endpoint, as well as most of the secondary and exploratory endpoints for both doses |
| It’s critical for many reasons we have discussed here today that we find an effective and safe treatment for patients with negative symptoms of schizophrenia |
| I would like to begin with the great news about our roluperidone program |
| So, really, I think, this is raising a lot of hope for patients and families in need of better treatment, because there is no approved treatment for negative symptoms currently approved in the U.S |
| Thank you so much and have a good day |
| Furthermore, our two late-stage studies have shown that improvement in the measures of negative symptoms translates into an improvement of daily function |
| Great |
| Great |
| We believe that these trials were adequate and well controlled for the proposals of submitting an NDA |
| to treat these symptoms and to the best of my knowledge, there are no drugs currently in development that have a specific and direct benefit on negative symptoms of schizophrenia, and very importantly, that translate into a functional improvement in patients |
| Again, to the best of my knowledge, roluperidone is the only drug that has shown both improvement of disease-related negative symptoms, and as a consequence, daily functional amelioration in patients |
| Congratulations |
| Good morning |
| Good morning |
| I would like to personally thank the FDA for the opportunity to have our NDA review and we look forward to continuing to work with the agency to address their questions |
| So good question |
| Geoff Race Good morning |
| Thanks all of you for the update and congratulations on that update |
| But I think it’s fair to say that we were probably able to show a minimum to the FDA that it is important to reduce this NDA and to go into the details of the different topics |
| Thank you so much |
| Thank you very much |
| Thank you |
| Thank you |
| Keep in mind that this is the first drug seeking to improve negative symptoms in patients suffering from schizophrenia, which has been filed |
| Good question |
| Statement |
|---|
| This is underscored by the lack of any approved drugs in the U.S |
| But is it surprising us? I don’t think so |
| For the three months ended March 31, 2023 and 2022, research and development expense was $2.7 million and $5 million, respectively, a decrease of $2.3 million |
| Negative symptom of schizophrenia are notoriously difficult to treat and as Dr |
| Last but not least, it is well documented in the scientific literature that antipsychotic drugs had block dopaminergic pathways in the brain may cause drug-related worsening of negative symptoms beyond the negative symptoms that are disease related |
| The FDA also noted that they had under defined as potential review issues |
| For the three months ended March 31, 2023 and 2022, general and administrative expense was $2.7 million and $3 million, respectively, a decrease of $0.3 million |
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