Here's where you're wrong:
1. "Ibalizumab has no side effects and no drug interactions. I am not sure why you think otherwise as there is no evidence to suggest that.
The fact that Ibalizumab has no side effects is irrelevant because it cannot be used as a monotherapy. Ibalizumab MUST be combined with a normal HAART treatment, which has many, debilitating side effects. Thus, the side effects of HAART are the side effects of Ibalizumab (heres the short list...hypersensitivity or allergic reactions, with symptoms can such as: bleeding, bone loss, heart disease, high blood sugar and diabetes, lactic acidosis (high lactic acid levels in your blood kidney, liver, or pancreas damage, headaches, nausea, insomnia, etc.) Side effects of a once a week shot of pro-140? Headaches and diarrhea in 14% of patients. You chose.
2. "Both PRO 140 and Ibalizumab work very well. Ibalizumab covers the whole HIV marketplace and PRO 140 only a portion."
Does ibalizumab really cover all patients? Kind of, but that's not the intended market. Ibalizumab is for HIV MDR patients or "treatment-experienced HIV patients". That's a small market. Yes, ibalizumab COULD be used on all HIV patients but its effect is no different from current medications and would still need to be combined with HAART. The phase IIb trial that ibalizumab performed well in was for HIV MDR patients.
3.) "Both PRO 140 and Ibalizumab work very well. Ibalizumab covers the whole HIV marketplace and PRO 140 only a portion. PRO 140 requires an expensive and time consuming tropism test while Ibalizumab does not (since it covers all HIV patients). That has been a problem for CYDY in terms of the cost of testing and the ability to find patients for its study. It is also why the company has been trying to get away from doing tropism tests but the FDA will not let them. IT is a big issue for them."
Again, you present information without providing all the facts. The tropism test costs $1-2K but the cost of the tropism assay is covered by most third-party insurance carriers, as well as Medicare and Medicaid and, in some states, the AIDS Drug Assistance Programs. Additionally, that test can provide healthcare providers with the necessary information to treat a patient according to the strain of HIV that they have. Why would an insurance company pay for HAART and the accompanying meds for side effects when they can pay for pro-140, with zero side effects? Pro-140 provides long-term cost savings over any current treatment, by far.
4.) "Ibalizumab will initially hit the market as a once every two week IV but within a year will likely be available in a once every two week injection. The simply need to do a bioequivalence trial, which will take roughly six months and then wait for the FDA to approve it (assuming it shows bioequivalence which seems highly likely)."
Again, this is irrelevant as this is for an HIV MDR patient will still require HAART regime EVERYDAY, orally. So HIV patients get an IV every two weeks but are still extremely sick from side effects.
5.) "Many here seem to be vastly underestimating the financing challenge facing CYDY."
You really don't need to say this for the 15th time. Investors here are aware of the looming dilution and inability of management to move pro-140 along faster. TaiMed may be closer to approval, but that doesn't mean they spent any less time or money on developing ibalizumab. TaiMed got FTD in 2003 and its now 2016. CYDY acquired pro 140 in 2012.
"PRO 140 can still play a role in the HIV market but it has yet to demonstrate it has a clinical pathway to success."
Meh, kind of and kind of not. Pro-140 works, that's clear, but it needs to be proven by pivotal trial data. Once that data is completed in full, the clinical pathway will be developed. Again, ibalizumab is ahead of the game, not because its a superior product, but because it started sooner and has a much larger company driving operations.
