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| Statement |
|---|
| JDRF stands as the foremost global entity propelling transformative breakthroughs for type 1 diabetes |
| This achievement, alongside the full activation of all countries and DSMB's green light, provides substantial encouragement as we propel the trial forward |
| To sum up, Q3 and year-to-date, we have seen remarkable progress |
| We are enthusiastic about extending this research collaboration to assess the potential advantages of polyamines in immune modulation for hematologic malignancies |
| We are enthusiastic about backing the newly launched Phase 2 trial for early-stage type 1 diabetes run by Indiana University School of Medicine and funded by JDRF |
| and Germany, successfully activating all intended countries for the ASPIRE trial, which are now actively enrolling patients |
| This agreement not only broadens our range of partner supported programs, but also holds the potential for significant development milestone payouts |
| We are eager to continue creating value for our shareholders as we move ahead in the coming months and into 2024 |
| WorldMeds achieved key milestones related to eflornithine's clinical advancement, regulatory approval and commercial sales |
| The objective is to create innovative and effective treatments for patients facing significant medical challenges |
| We've successfully cleared a plan futility analysis and will continue the study |
| And as I mentioned in the remarks, it was a positive vote, and that then typically signals communication with the FDA |
| This effort exemplifies the company's continuous partnership with Johns Hopkins University School of Medicine |
| We view this ruling as additional validation of the potential clinical efficacy and safety of the drug and value that we expect to derive from its continued development |
| We warmly welcome U.S |
| After the quarter ended, the FDA's Oncology Drug Advisory Committee, or ODAC, noted that there was sufficient evidence to conclude eflornithine, or DFMO, reduces the risk of relapse in pediatric patients with high-risk neuroblastoma who are in remission and have completed multiagent, multimodal therapy |
| Previous clinical studies demonstrated the efficacy of BAT as a monotherapy and its ability to sensitize to subsequent androgen inhibition |
| According to Sims et al, although therapy of type 1 diabetes has improved, the morbidity, mortality and costs continue to impact the quality of life for those affected, highlighting the need for safe and effective therapies that address the underlying pathology |
| What I can tell you is that we have a great partner in Indiana University, and it is a multisite center |
| The goal of the androgen and polyamine elimination alternating with XTANDI, or APEX trial, will be to evaluate a treatment with a combination of DFMO or eflornithine in high-dose testosterone will improve the prostate-specific antigen, or PSA, response rate in patients with metastatic CRPC compared with historical controls |
| Jonathan Aschoff Thank you, guys |
| Thank you so much |
| Thank you very much |
| Thank you |
| Thank you |
| These findings collectively indicate the potential for a targeted polyamine therapy in conjunction with CAR T therapies |
| Statement |
|---|
| Net loss in the third quarter of 2023 was $7.8 million, or $2.69 per diluted share compared to a net loss of $4.4 million, or $257.36 per diluted share in the third quarter of 2022 |
| The FDA stated that the high unmet medical need for patients with neuroblastoma, a specific external control data source, and the results of the propensity score matched analysis impacted their willingness to consider an external control design in this circumstance |
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