The coronavirus pandemic has been one of the biggest healthcare crises in history and even now there is no end in sight. A vaccine has not yet hit the market and the pandemic continues to rage. However, many companies are working on a COVID 19 vaccine at this point and many of these companies have seen their stocks soar on the back of optimism among investors.
One such stock is that of CytoDyn Inc (OTCMKTS:CYDY) and on Thursday, the stock rose further after an important development with regards to its coronavirus vaccine. The company announced that it is all set to make requests for pre-submission meetings with authorities in the United Kingdom for getting approval for its COVID 19 vaccine leronlimab for use in COVID 19 as well as in HIV positive patients.
It is a major development for the company since it opens up a new market and also the possibility of having an additional use for the product. The news was well-received by the market as well and the stock rallied by as much as 8% following the announcement. That being said, it needs to be recognized that the whole thing is still at a preliminary stage and investors would need to keep an eye on all the developments over the coming days.
CytoDyn is going to make the submission to the Medicines and Healthcare Products Regulatory Agency and in this regard, it should be noted that the Phase 3 trial of leronlimab on HIV patients had in fact met the primary endpoint. Hence, it is going to be interesting to see how the whole thing progresses.
However, that is not all. There was other positive news last week in relation to leronlimab as well. The company announced that an independent Data Safety Monitoring Committee had made a safety review of Phase 3 clinical trial of its coronavirus vaccine leronlimab and found no cause for concerns.
The committee made a review of the trial which is going to be made up of patients with severe symptoms of COVID 19 and in its report; it stated that there was no safety-related reason for modifying the study. The company has already enrolled a total of 169 patients for the Phase 3 study and it goes without saying that it is of critical importance. The report from the committee is another important milestone for CytoDyn.
Lastly, it should also be noted that the company is unlikely to have any problems with regard to the financing of this project. At the end of July, CytoDyn announced that it raised as much as $28.5 million as part of a non-convertible debt offering from an institution. Out of that capital, $25 million was made available immediately.
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