CNS Pharmaceuticals Inc (NASDAQ: CNSP) today announced that the U.S. Food and Drug Administration (FDA) had approved Fast Track Description for its untried lead medication, Berubicin, for the cure of patients with recurring glioblastoma multiforme (GBM).
Drug to be used for the Cure of Recurring Glioblastoma Multiforme
The company has also obtained Orphan Drug Description from the FDA for Berubicin to cure patients with recurrent GBM.
“Getting Fast Track Description from the U.S. FDA is a huge attainment in our progression of Berubicin for the cure of glioblastoma, the most hostile, lethal and treatment-resistant type of cancer that forms in the brain. If there were ever an illness where the unmet medical need mandates action, it is GBM. Patients have almost no significant choices and thousands lose their bout against this terrible cancer every year. With this description, we now have an enhanced pathway to endorsement for Berubicin and a clear prospect to more advantageously bring this hypothetically impactful tentative treatment to persons fighting this perplexing illness,” commented John Climaco, CEO of CNS Pharmaceuticals.
Fast Track Description permits more frequent communications with the FDA to accelerate the growth and appraisal process for drugs envisioned to treat grave or life-threatening disorders. That validates the latent to address an unmet medical need.
CNS lately announced the start of patient registration in its possibly essential study of Berubicin to cure recurring glioblastoma multiforme.
Précis of Financial Outcomes for First Quarter 2021
The net loss for the three months finished March 31, 2021, was about $3.6 million, equating to around $2.0 million for the comparable period in 2020. The alteration in net loss is attributable to augmented workers and activities related to formulating for the company’s scientific trials in 2020.
The company conveyed Research and development expenditures of $2.2 million for the three months ended March 31, 2021, equated to about $0.6 million for a similar period in 2020.
Broad and managerial expenditure was about $1.4 million for the three months ended March 31, 2021, equating to around $1.3 million for the comparable period in 2020. The company completed the quarter with $11.0 cash and cash equivalents, projected to fund processes into 2022.