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  4. CytoDyn Inc (CYDY) Message Board

I agree that there is little to zero downside in a

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Post# of 153905
(Total Views: 481)
Posted On: 01/13/2020 9:02:00 AM
Posted By: sjacobs26
Re: SouthernGold #14898
I agree that there is little to zero downside in applying for BTD early.

IMO the worst case scenario is that the FDA ask for more data before making a decision (not disapproval, but delay to get more data points).....filing for BTD and announcing today will only help with visibility and enrollment which should speed up getting these data points. *Note that any delay in BTD approval would likely be the baseline timeframe if CYDY waited until they had more data before filing.

Given the data from the first 2 patients and safety of leronlimab, I don't see how the FDA could deny BTD.....only ask for more data as noted above. Best case is this was discussed with FDA prior to filing and they approve BTD.

IMO both scenarios are huge wins for the patients, the company and the investors. IMO we are still significantly undervalued for combo HIV......TA indicators will go 'off the charts' crazy if decent valuation ever gets assigned to the share price with even a smidge of cancer potential!


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