Dr. D has apparently shown evidence on twitter tha
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BUT!
She has very strong pie in the sky tendencies with her predictions, which often read like they're inevitable facts. The clearest example I have of this is reading her on YMB leading up to the moment we weren't given a BTD for mTNBC. In the month or so leading up she was basically saying it was a done deal, and as it got closer her posts became more definitive about the inevitability of the decision. And if I remember correctly there were also some posts alluding to some contact that she had that was telling her all eyes were on LL at the FDA, or whatever. Basically making it sound like she had a bit of an inside look to back up her extremely optimistic opinions.
Of course maybe there were lots of eyes on LL but for the wrong reasons.
"Hey Jim, get over here and look at this BLA some illiterate child must have sent over! mistakes everywhere, lol. I've never seen anything like it! Earl! Get over here and see this!"
And in her defense, while we didn't get the designation it doesn't mean we shouldn't have been a virtual shoe-in for one. Plenty of arguments can be made about how management decided to build and ultimately present the data they had. But her optimism wasn't unwarranted, just applied with an inappropriate amount of vigor.
That's her downfall.
It clouds her judgement when it comes to her near term outlook or predictions. She believes, naively but sweetly, that everyone within our government has only our best interests at heart and will move mountains to do the right thing. And of course we all know that it's not, and never will be, a level playing field for companies like Cytodyn. Oh they'll move mountains, they just won't do it for Cytodyn.
Back in the day a good friend of mine introduced me to one of his best friends from his formative years. She had a one year old baby girl at the time who was smitten with me. A short time later my friend's friend was diagnosed with small cell ovarian cancer and died within three months. Everyone, of course, jumped in to help raise money for both the family and for small cell ovarian cancer research. At one point there was a lot of money to donate. Something like 25-50k. The family went to donate it for small cell research and was told they couldn't guarantee it would go to that, and in reality it was almost certainly going to be used to help bolster regular ovarian cancer research. Or that it could also go toward administrative stuff. Such bullshit. So they decided to use the money to help create a wonderful and relaxing space for anyone being treated at the facility instead so they still had some control over how it was used.
My point in telling you the story is that these things (large organizations, the FDA/Government) are like big machines that can't easily be altered or adapted to change course. Nobody there has the autonomy to make real change and the disruption to their day or career is not worth it to them. To the gut, or the cockles, or wherever our common sense lives (I'm not a geologist), it makes all the sense in the world that you could take all the pieces that make up the FDA and reorganize them into something more efficient, and that everyone there would be on board. But it's just not the case.
Long story short, I'd take anything Dr. D says and immediately chop away 75% of the optimism. You'll still be left with a postiive outlook on our boy Leron, but you'll avoid getting let down when the FDA doesn't immediately declare every day ending in Y as Leronlimab Day and rush through an approval.