One of the more popular investment themes over the course of the past few months has been the one around coronavirus. Many pharmaceutical and biotech companies that are working on coronavirus medicines, vaccines, or testing products have seen their stocks soar due to heightened investor optimism.
Receives CE Mark for Licensed COVID-19 Molecular Tests
One such company is Pharmacyte Biotech Inc (OTCMKTS:PMCB), which had started marketing COVID 19 molecular tests after having to license it from Hai Kang Life Corporation. However, earlier this week, the company made a major announcement with regards to its testing product and that has now seen the PharmaCyte stock soar by as much as 10%. In this sort of situation, it could be worthwhile for investors to take a closer look at the company and its operations.
On Wednesday, PharmaCyte announced that its COVID 19 molecular tests have been given the CE Mark and that proved to be the trigger for the strong rally in the stock. Investors should also note that the CE Mark has been awarded to the RT-PCR and ERT-PCR tests.
It is a significant development for the company since the Declaration of Conformity for these tests indicates that it also essential requirements In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC) for the European community. The CE Mark will also help PharmaCyte to market its products in the European Union and that is a major boost since it opens up a massive market for the company.
Submission of Drug Master File to FDA
However, that is not all. Earlier this week, there was another important development that has raised optimism levels among investors. The company announced this Monday that Austrianova, its partner, has submitted a Drug Master File to the United States Food and Drug Administration. The Drug Master File related to CypCaps, which was produced by Austrianova and is going to be used in PharmaCyte’s clinical trial for LAPC (locally advanced, inoperable pancreatic cancer).
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, stated that it is an exciting milestone for the company and is going to help the company in accelerating its goal of placing an Investigational New Drug Application (IND). He went on to stated that the submission of the Drug Master File is an important milestone since it represents the last requirement before the company can start its application process for submission to the FDA.
Earlier on in June, there was another important development that had created a certain degree of optimism about the company’s pancreatic cancer product. Back on June 10, the company announced that it was successful in incorporating the ‘change history’ feature in its pancreatic cancer product. It was another important milestone for the company as it continues to fine-tune the product. Investors could do well to keep an eye on the product.
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