Market cap too low for Phase III company.
Cytodyn not only has a Phase III drug, PRO 140, that is on the verge of being approved for HIV in combination with HAART drugs, but it is in clinical trials for other indications, including GVHD.
It appears the odds are very good that Cytodyn will meet its primary endpoint for the combo HIV study. Once that happens, the company has said it will apply for BTD. Based on this new data, BTD is likely to be granted this time.
After PRO 140 is approved for use in combination with HAART drugs, it could become a more attractive target for possible suitors or partners.
Although the label will initially say PRO 140 is only approved for use in combination with other drugs, many will no doubt use it off label as a monotherapy in order to avoid the toxic effects of HAART. We could then start hearing from patients using PRO 140 as a monotherapy, which should create a big buzz even before it is approved for this indication.
While the combo trial in winding down, the monotherapy trial is gearing up, and patients are being dosed in this study as we speak. Per previous announcements, the company expects this Phase III trial to be fully enrolled by YE 2017 with topline results to be announced soon thereafter.
And let's not forget that executive chairman,Tony Caraciollo, just invested $1,000,000 of his own money in the current raise, while director Carl Dockery has invested millions of his own money in the company as well. Insiders do not invest to lose, and these two insiders must have a high level of confidence in the company's success for them to invest as much of their own money as they have.
While watching the day to day gyrations in the share price, and trying to predict where the price will go based on technical analysis, is a useful exercise, the share price will ultimately reflect the company's fundamentals that appear to be tilting strongly up at this point.
Thus, those who invest at today's levels are likely to enjoy significant gains, IMHO.
