Besides the degree to which the FDA would politicize approvals during a world pandemic, I am surprised by the change in tone by many longs of late. Given the billions of dollars big pharma stands to lose, why wouldn’t anyone expect this to be a battle.
My one criticism against NP is that he, like most newbie CEOs with a deep technical background, believed the product would speak for itself. Therefore, all in the name of “transparency” they attempted to provide numerous “specs” and “details” instead of a prepared, rehearsed, and clear message. They also fail to realize when to say nothing at all, because that skillset is less developed. More importantly, they place overwhelming trust in the referees (e.g. government agencies) being fair and neutral because within an organization that is expected to crank out the best product.
I’ve worked for CEOs like above, trying to be like Gates, Jobs, or Musk, and they all make similar mistakes. That said, this is the boat we’re in, and so what are the alternatives for the next 3 months?
If we take the conspiracies off the table, it is quite clear that the FDA favors strategies that attack viruses head on and will reduce viral load, and that is not our (currently recognized) MO. Even if FDA officials understand our MO, telling the general public that something directly attacks the virus is likely to gain more acceptance and use among the public (and general practitioners) rather than try to explain what an immunomodulator is.
What we want the FDA or any other health agency to be able to say to the public is that “Vyrologix will prevent you from dying from Covid or any of our numerous potential indications!” This also why we shouldn’t do anything to jeopardize this message, including unblinding data and taking a penalty, particularly given that we are not cherry-picking participants and the SOC is improving.
Advocates for unblinding the data are also believing that the product will just speak for itself and ignoring all the social dynamics of governments telling the public to trust a small, relatively unknown biotech company.
Don’t provide reasons for governments to say no, whether technical, political, or otherwise! Comply with all rules and recommendations until you have built sufficient leverage before trying to circumvent any part of the process!
All IMO
