my guess on upcoming catalyst (from a stock price perspective):
2-3 months getting the clinical hold lifted - I think this is very important as it is holding up the HIV BLA and all partnerships in other indications. I doubt any potential partner will sign the paperwork until this is resolved. all other indications are built on the safety data from the HIV trial and the manufacturing portion of the BLA in HIV. with both of those buttoned up, the only thing left to trial is the effectiveness and dosing.
2-3 months - submit HIV BLA - this should come immediately after the clinical hold it resolved. this could have the biggest impact on the stock price this year, however the stock price jump might occur once the FDA gives the acceptance of the BLA rather than Cytodyn submitting the BLA. This must happen this year. Once we have this, the drug is almost certain to be a revenue generator and the claims are real. Investors will jump in at this time. Leronlimab is greatly de-risked.
post clinical hold resolution - all other than HIV indications are open for partnerships, they can happen at any time. Our new president/CEO is young fund raiser/deal maker. I do not see a buyout prior to partnerships, that is just how the process typically goes in my research. The nature of these partnerships i would think is a foundation of funding and regulatory support that Cytodyn lacks in return for part exclusive rights to leronlimab for the partner. the days of fund raising are gone after this. No partner is going to risk their investment because Cytodyn can't pay the payroll. I still have no idea how the list of indications gets split from one partner to another, but this does happen. it is just rare that the other indications are so developed concurrently, typically a partner steps in for one indication and other indications are discovered later. this might lead to a very big partnership or a lot of little partnerships.
These are the only events i see this year at best, however, they will send the stock price to a new higher level. this stock price is showing a very high risk company, we hopefully end the year being greatly de-risked. risk is our suppression, low double digit stock price is going to be built on established low risk.
I am not too good about figuring out when actual approvals occur, mostly because these depend on the FDA and partners. The lawsuit future against Amerax also is not predictable other than it will be years of legal stuff before any settlement happens. Maybe a case filed against Amerax for damages will propel the stock price some, but i don't know.
2-3 months getting the clinical hold lifted - I think this is very important as it is holding up the HIV BLA and all partnerships in other indications. I doubt any potential partner will sign the paperwork until this is resolved. all other indications are built on the safety data from the HIV trial and the manufacturing portion of the BLA in HIV. with both of those buttoned up, the only thing left to trial is the effectiveness and dosing.
2-3 months - submit HIV BLA - this should come immediately after the clinical hold it resolved. this could have the biggest impact on the stock price this year, however the stock price jump might occur once the FDA gives the acceptance of the BLA rather than Cytodyn submitting the BLA. This must happen this year. Once we have this, the drug is almost certain to be a revenue generator and the claims are real. Investors will jump in at this time. Leronlimab is greatly de-risked.
post clinical hold resolution - all other than HIV indications are open for partnerships, they can happen at any time. Our new president/CEO is young fund raiser/deal maker. I do not see a buyout prior to partnerships, that is just how the process typically goes in my research. The nature of these partnerships i would think is a foundation of funding and regulatory support that Cytodyn lacks in return for part exclusive rights to leronlimab for the partner. the days of fund raising are gone after this. No partner is going to risk their investment because Cytodyn can't pay the payroll. I still have no idea how the list of indications gets split from one partner to another, but this does happen. it is just rare that the other indications are so developed concurrently, typically a partner steps in for one indication and other indications are discovered later. this might lead to a very big partnership or a lot of little partnerships.
These are the only events i see this year at best, however, they will send the stock price to a new higher level. this stock price is showing a very high risk company, we hopefully end the year being greatly de-risked. risk is our suppression, low double digit stock price is going to be built on established low risk.
I am not too good about figuring out when actual approvals occur, mostly because these depend on the FDA and partners. The lawsuit future against Amerax also is not predictable other than it will be years of legal stuff before any settlement happens. Maybe a case filed against Amerax for damages will propel the stock price some, but i don't know.
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