Replies to post #17655 on Cytodyn Inc (CYDY)

[fred198484]

I agree with much of what you have said here. There is little doubt the interim results will be good. The key issues now are how long it will take to recruit the needed patients (an estimated 10 for combo and an estimated 150 for mono) and how much money will need to be raised to get there and beyond.

They need to raise the money first since recruiting and treating patients costs money and hopefully, we will hear more about that on 10/19. How much will the raise and at what price? Clearly the capital raise will come after the interim PR result is released as that should help the share price and encourage new buyers to take a chance on investing in CYDY.

So, let's take a guess at timing. I suspect the interim PE results can be completed by 11/5. A fundraising should happen within one week of that. The additional 10 patients in the combo might take another 2 months but that really is not likely to be the controlling issue. That will be how long it takes to get the extra 150 patients in mono. I am going to say that takes at least six months. Hopefully I am wrong about that and maybe the only reason they don't have more already is that they simply did not have the money needed to recruit more faster. Using the six months, however, puts you in April 2018 or so. Then you need the last patient to complete 24 weeks. So that puts you in the September/October 2018 time frame. Then you have to put together the BLA and you should probably assume at least three months for that (could be longer if Theratechnologies is a relevant indicator as it took them about 6 months). So, we are now at the beginning of 2019. If the FDA does not agree to some form of speedy review, you are looking at an FDA decision at the end of 2019/early 2020.

They will need a considerable sum of money to get there. I doubt very much they will try to raise all of what would be required anytime soon but they will likely need to raise a significant amount of money. Maybe $20 million now and the rest later? The dilution will hurt but the deal will hopefully be done at a higher share price post the interim PE results.

For those who have been waiting a long time already for your ship to come in on CYDY, you likely are looking at more than 2 additional years before PRO 140 finally generates revenues (assuming the FDA does not mess with them anymore by changing criteria or asking for additional info). But if they can raise the needed money, they should make it to commercialization. While the FDA has toyed with them on the combo study, they gave them a much needed helping hand with the ability to announce the interim PE data.