Agreed, Grip.
True statements. But there is an equally true opposite for those statements:
- There is nothing that proves any sort of approval is NOT coming.
- Nobody can say for fact that the discussions AREN’T about approval.
The HIV BLA was not rejected. A BLA which was not filed cannot be rejected. As a result of those “helpful” discussions you mentioned, the FDA told CytoDyn not to file the BLA yet because they had more questions they wanted addressed. And yes, HIV has now been pushed out a year. I personally tend to believe that switching focus to COVID mid-stream will do that, especially when you’re a pre-revenue biotech. In the end, though, I’m OK with it. Because it gave them the time to hire Dr. Rahman, who I believe will make sure that it’s completely ready the next time they do discuss submission with the FDA.
They were only in “talks” about M/M in the sense that they discussed with the FDA whether the results from CD10 were strong enough for an early approval. Receiving any kind of approval after a Phase 2 trial is not the ordinary course of action. Phase 2s are normally about setting up the Phase 3 trial, which IS what normally leads to approval. So after CD10 they asked FDA if the results were likely to result in approval. The FDA said “No. We want you to proceed to Phase 3.” So they did. And now here we are.
It’s almost impossible to prove a negative. So there’s not really a way to refute your claim that “many longs have left”. But it’s also very difficult for you to disprove a claim like “Many more longs have bought in than have left” or “Many more shorts have cleared their position in the last couple of weeks than have taken new short positions.”
The CEO’s track record is OBJECTIVELY NOT 0%. FOUR HIV trials have been completed. The entire company pivoted to COVID in early 2020 and started CD10. CD10 was completed. CD12 was completed. COVID Long Haulers trial was approved and will fill VERY quickly. Those are all valid deliverables that any biotech company has to go through on the road to proving and receiving approval for a drug.
But some people only want to focus on the fact that CytoDyn has not yet received an approval. I must sound like a broken record by now, but I’ll say it again: That fact is true for EVERY SINGLE BIOTECH COMPANY in existence at some point in their existence. Every company has a period of time during which it has not gotten a drug approved.
