TSOI, today announced that the US Food and Drug Administration has cleared the company to initiate a pivotal trial for the registration of JadiCellTM for the treatment of COVID-19-associated lung failure. Because of this announcement, the stock skyrockets by 77.58% in the market. Though the company has only $154.7 million of market valuation.
JadiCellTM is a unique product that can be used to treat a variety of diseases and conditions. Its superior activity has been shown to be superior to other types of stem cells. In a double-blind placebo-controlled clinical trial, JadiCellTM was 100% effective at saving the lives of patients with COVID-19.
The Company announced getting an allowance from the FDA for its Phase III clinical trial of YC-CoV-2. This clearance allows the Company to initiate the clinical trial before commercializing the product. Dr. James Veltmeyer, the Company’s Chief Medical Officer, said that he was excited to join the clinical development of JadiCells. Despite the initial promise of vaccines, many people still refuse to vaccinate. With the current clearance, COVID-19 can now be used to develop new treatments for this patient population.