Thanks, and you're welcome, glad you found it helpful. As to the question of why the delays, my personal opinion is that it's one part sins of the past from long ago coming back to haunt them, one part insufferable FDA bureaucracy, and one part money being tight. Although at times I've wished that they would focus and get this one thing done, in the end I think it's been wise to chase the extracurriculars and it probably hasn't slowed them down much.
Sins of the past:
- In short, the vast majority of delays seem to be due to questions about appropriate or preferred dosages. The earliest P1 trials - from before the days of NP and CytoDyn even - should have probably done a better job of finding a maximum tolerable dosage, etc. They didn't, and one way or another, we wound up doing the combo P2/3 trial with 350mg originally. Eventually we were running mono trials as well, moved to 525mg then 700mg, were mixing trial protocols a bit... and all of the sudden you simply have a mess where the FDA has to figure out what it wants and the company has to respond to that. A more thought out, consistent clinical program would have been more efficient. Not all of that is NP's fault, some of it was likely a result of him learning on the go though. To the point that trding has made before, however, most "experienced" CEO's probably wouldn't have even tried any of this and wouldn't have the company or drug where it is now.
FDA is a huge bureaucracy
- I'm not going to expand on this one much, but the FDA is simply slow and bureaucracies are inefficient and innately poor structures for adapting quickly to new circumstances. Everything takes time, and the process is inscrutable looking from the outside in. If you're interested in why this is so innate to bureaucracy, skim or read "The Essence of Decision" by Allison and Zelikow. Fascinating read, in my opinion, but also does a great job of academically explaining the characteristics of bureaucracies that make them inefficient decision makers. The FDA is no exception.
Lack of money
- Simple. We're paying Amarex to put the BLA together. We're paying AGC for the stability data, etc. We've been asking to defer payments, put it on a credit card, etc. Ask any of the many lawyers here... the client with the money gets the work done first. We finally have the money to pay them, so I'm pretty confident that it'll get finished up at this point.
Aside from the money issue, I don't think that cancer, etc., has played a major part in the slow down. And at the moment, I'd say that money spent on cancer and coronavirus has been money well spent, even if you couldn't have necessarily foreseen it playing out this way.
Sins of the past:
- In short, the vast majority of delays seem to be due to questions about appropriate or preferred dosages. The earliest P1 trials - from before the days of NP and CytoDyn even - should have probably done a better job of finding a maximum tolerable dosage, etc. They didn't, and one way or another, we wound up doing the combo P2/3 trial with 350mg originally. Eventually we were running mono trials as well, moved to 525mg then 700mg, were mixing trial protocols a bit... and all of the sudden you simply have a mess where the FDA has to figure out what it wants and the company has to respond to that. A more thought out, consistent clinical program would have been more efficient. Not all of that is NP's fault, some of it was likely a result of him learning on the go though. To the point that trding has made before, however, most "experienced" CEO's probably wouldn't have even tried any of this and wouldn't have the company or drug where it is now.
FDA is a huge bureaucracy
- I'm not going to expand on this one much, but the FDA is simply slow and bureaucracies are inefficient and innately poor structures for adapting quickly to new circumstances. Everything takes time, and the process is inscrutable looking from the outside in. If you're interested in why this is so innate to bureaucracy, skim or read "The Essence of Decision" by Allison and Zelikow. Fascinating read, in my opinion, but also does a great job of academically explaining the characteristics of bureaucracies that make them inefficient decision makers. The FDA is no exception.
Lack of money
- Simple. We're paying Amarex to put the BLA together. We're paying AGC for the stability data, etc. We've been asking to defer payments, put it on a credit card, etc. Ask any of the many lawyers here... the client with the money gets the work done first. We finally have the money to pay them, so I'm pretty confident that it'll get finished up at this point.
Aside from the money issue, I don't think that cancer, etc., has played a major part in the slow down. And at the moment, I'd say that money spent on cancer and coronavirus has been money well spent, even if you couldn't have necessarily foreseen it playing out this way.
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