Should You Buy CytoDyn After This Week’s Steback?
Over the past months, many companies have seen their stock prices on the back of their work related to products meant for tackling the coronavirus pandemic, and one such company is CytoDyn Inc (OTCMKTS:CYDY). The company came up with a medicine named leronlimab that could be used to treat coronavirus patients, and that created a lot of buzz around CytoDyn.
FDA Seeks More Information
However, on Tuesday, the company got a bit of a setback regarding leronlimab in a related matter. The company had been looking for approval for treating treatment-experienced HIV patients through a combination of leronlimab and HAART (highly active antiretroviral therapy), and yesterday, it was issued a Refusal to File Letter by the FDA.
The United States Food and Drug Administration’s letter is an indication that the application made by CytoDyn was not satisfactorily complete for the agency to conduct a full review. However, it does not seem that all is lost for CytoDyn since the company aims to request a meeting with the regulatory agency and discuss the situation.
The company did clarify that the FDA has not actually asked for more clinical trials but demanded more analyses of the completed studies. It is something that the company claims it can furnish ‘as soon as possible.’
However, that is not all. The company also revealed on Tuesday that it also aims to unblind and lock the data from the Phase 2 clinical trial of leronlimab on COVID 19. In addition to that, investors need to keep in mind that the company is also conducting a safety review of the data points from the Phase 3 trial of the product on coronavirus patients next week. It should be noted that the assessment will be done independently by the Data Safety Monitoring Committee. CytoDyn is also going to host a conference call regarding this matter today.
The CytoDyn stock has done reasonably well over the past weeks, but it remains to be seen what effect the latest letter has on it. Investors could do well to keep one eye on the stock over the course of the coming days. That being said, it should be noted that coronavirus cases are again on the rise, and many market watchers will also be tracking the company’s progress with regards to leronlimab’s effect on COVID 19.
Earlier on in July, the company made a significant announcement that proved to be a major positive. CytoDyn announced that it inked an exclusive Distribution and Supply Agreement with the company American Regent Inc for its product leronlimab. The agreement in question is with regard to the distribution of the product for coronavirus patients across the United States. The company is going to get quarterly payments from American Regent on a profit-sharing basis.
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