So when I look at the history of The company’s g
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NASDAQ: it was obvious to me when Mullholland wandered all over the place in the August meeting about what they needed to do for NASDAQ, I threw up my hands. He said a lot of words that meant nothing to the point it sounded like he was unprepared to answer the question. That told me there was more than one box that needed to be checked that was going to be challenging at this time. It will eventually happen but not now.
Second, the BLA for the FDA sounded like Cytodyn was poorly prepared . It’s not the first time that a Pharma company has struggled with a BLA . I am sure they will gather themselves and nail it down but I don’t think they have people on board who understand what’s important in the process. Hopefully they have covered that gap in some way and will continue to get this HIV drug to market next year
Now on the good: this company’s stock has jumped in a year and has a market cap over a billion dollars, closer to two billion. The CEO and team work their butts off in a tough environment controlled by big Pharma with powerful relationships in Washington DC , and a bottomless pit of money to pay lobbyists. Cytodyn has around 18 employees and has to watch every dime they spend . They have continually gotten the cash they need to operate the business. Since I bought the shares they have gone from zero patients in trials for Covid to getting to where we are today. EUA requests and successful trials up to this point and potentially on the verge of either an EAM in the UK and/or approvals in both the US and the UK for Covid..
The NASDAQ piece will be great when it happens but has nothing to do with getting drugs approved but the BLA is a different story and they need to shore up their weakness there. it’s the trials and approvals that’s important..Truly doing very well to get where we are since February for Covid and dealing with the issues of being small in a Big company world . I hope the management team continues to learn and refine their communications skills and focus on getting Leronlimab to market for their first application.