RE: CMB International Target Price HK$51.15 / £5.196 May 2022 13:49
FDA is in a responsible position of approving any new therapeutic methods for US health care system. In Surufatinib’s case, although they agreed to consider the initial application for approval, travel restrictions due to the pandemic might have stopped the FDA team/s from conducting first hand onsite verifications at the oncology units (which took part in phase 3 trials) and also the manufacturing facilities on mainland China. If the FDA professional team/s had been able to conduct required inspections in China, the results of the application could have been different.
Pancreatic and Extra-pancreatic Neuroendocrine tumors continue to have no known/ established therapy, as per the company’s recent news release. Oncology fraternity in the USA (and other parts of the world) would have been benefited with the availability of the new medication. It is not just disappointing to the investors but also to the deserving patients and their oncologists. But, from FDA’s point, one can assume, the approval team of professionals have taken a safer stand for the time being. Hence, the suggestion/advice to Hutchmed to conduct additional MRCTs. New CEO sounded confident in taking up the challenge.
In the mean while, shorters have filled their coppers in a big big manner at the cost of dedicated investors.