I took a quick look at the timeline of Humira's development and there are some key milestones:
1998 - developed drug
1998 - phase 1
2001 - bought out by Abbot for $6.9 billion
2002 - 1st FDA approval
2005 - 2nd FDA approval
If Cytodyn is following this model, we are at year 8 of the 14 years it took to get FDA approval. We can say that where leronlimab entered Cytodyn, it was further along than Humira was in 1998. I would say that if in the next year Leronlimab gets approval for HIV combo we are roughly on this timeline. Not that it has not been a bumpy road but I don't think it was smooth for Humira either.
The big difference is the buyout prior to the FDA approval - this could be a very important difference. I am sure Abbot has the ability to get an FDA approval far easier than Cytodyn and the investors got a big payday prior rather than big dilution we got. Not having a deal by now for one indication is a big handicap.
From that buyout and 1st approval it has been all expanding into other indications and growth. I wonder if all the other indications Cytodyn has been chasing are really out of the timeline and distractions from just getting a partnership/buyout for what they have. On the otherhand, a $6.9 billion buyout is not what us investors want, we want $20+ billion. We have to have more than HIV potential and we need the other indications to be quite certain as real possibilities. We don't need phase 3 trials, buyouts happen at phase 1 and 2, by phase 3 they missed the window and failed to get a deal.
1998 - developed drug
1998 - phase 1
2001 - bought out by Abbot for $6.9 billion
2002 - 1st FDA approval
2005 - 2nd FDA approval
If Cytodyn is following this model, we are at year 8 of the 14 years it took to get FDA approval. We can say that where leronlimab entered Cytodyn, it was further along than Humira was in 1998. I would say that if in the next year Leronlimab gets approval for HIV combo we are roughly on this timeline. Not that it has not been a bumpy road but I don't think it was smooth for Humira either.
The big difference is the buyout prior to the FDA approval - this could be a very important difference. I am sure Abbot has the ability to get an FDA approval far easier than Cytodyn and the investors got a big payday prior rather than big dilution we got. Not having a deal by now for one indication is a big handicap.
From that buyout and 1st approval it has been all expanding into other indications and growth. I wonder if all the other indications Cytodyn has been chasing are really out of the timeline and distractions from just getting a partnership/buyout for what they have. On the otherhand, a $6.9 billion buyout is not what us investors want, we want $20+ billion. We have to have more than HIV potential and we need the other indications to be quite certain as real possibilities. We don't need phase 3 trials, buyouts happen at phase 1 and 2, by phase 3 they missed the window and failed to get a deal.
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