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Posted On: 05/07/2019 8:20:35 PM
Post# of 150981

Re: ClosetInvestor #2647
I guess it depends on what the expectations are and what the actual protocol ends up being. If 300 patients at 48 weeks then that will be much longer than 100-150 patients at 24 weeks. At this point we don’t know, but both could be in play or something in between? I know initiating the trial will take some time along with enrollment and some data consolidation to prepare the supplemental package on the back end, but I expected that. Something working in its favor is enrollment should be easier (compared to combo) and FDA approval should be lessened with the expansion label.
IMO approval could come in 2H2020 (best case and better than I originally anticipated) or sometime in 2021 (end of 2021 worst case), either of which are much better than A17 projections. I could be wrong and as I previously mentioned, mono doesn’t matter to me until our financial challenges are resolved or it is approved (thus why I removed it from my valuation estimates other than salvage value in case cancer doesn’t work as I expect it will)......plus my thought is they will license HIV and this lessens the revenue potential for CYDY to a fraction of the estimates they have provided. Combo isn’t that important from a revenue perspective (unless they fail to close a license deal for HIV), but more so for approval to allow the expansion label approvals.....which is why I also exclude these revenues except salvage value. Any positive surprise for HIV is welcomed though. I’m sure some will disagree, but I am just providing my thoughts/opinions based on what I currently expect. This could all change as further details emerge.
IMO approval could come in 2H2020 (best case and better than I originally anticipated) or sometime in 2021 (end of 2021 worst case), either of which are much better than A17 projections. I could be wrong and as I previously mentioned, mono doesn’t matter to me until our financial challenges are resolved or it is approved (thus why I removed it from my valuation estimates other than salvage value in case cancer doesn’t work as I expect it will)......plus my thought is they will license HIV and this lessens the revenue potential for CYDY to a fraction of the estimates they have provided. Combo isn’t that important from a revenue perspective (unless they fail to close a license deal for HIV), but more so for approval to allow the expansion label approvals.....which is why I also exclude these revenues except salvage value. Any positive surprise for HIV is welcomed though. I’m sure some will disagree, but I am just providing my thoughts/opinions based on what I currently expect. This could all change as further details emerge.


Please do your own due diligence. All my posts and comments are not to be considered investment advice.
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