Here are my comments on your statements about Ibalizumab:
Your statement: Ibalizumab will be live saving for patients CCR5 negative , with resistance to HAART.
My comment: Correct. More specifically, it will be used for patients with multi-drug resistance, which means resistance to at least three of the five classes of HAART.
Your statement: It is CD4 inhibitor , and most probably sooner on the market than Pro 140 , but IMO not a very big competition to it.
It is giving as an IV injection every two wks. So patients need to go to clinic or hospital every 2 weeks for IV infusion.
My comment: Ibalizumab has already been filed by Taimed (last week) is a Breakthrough Therapy drug and therefore will be given priority review. It will likely be on the market this Fall. Pro 140 has not yet completed it Phase III combo trial, which looks very much like Ibalizumab's yet the company does not talk about it being for MDR patients. It hopes to get Breakthrough Therapy status on the basis of those as yet undetermined Phase III combo results. Time will tell if it will get that, but they have a decent chance of getting it. Even so, it will likely be 2019 before PRO 140 gets on the market for combo therapy (primary endpoint in 7/17, test completed in December, likely filed with the FDA in March 2018, likely approved in November/December and finally on the market in early 2019). And the first mover advantage for Ibalizumab is going to be very significant. Moreover, the MDR market has very few patients who who are CC5 that PRO 140 addresses since treatment experienced patients (which are what all MDR patients are by definition) have migrated to the CC4 version of the HIV virus. Moreover, Taimed's partner Theratechnologies is arranging for a nurse to come to your home or office to give you the infusion. These are the reasons CYDY is downplaying the combo therapy trial and Ibalizumab's extended access program may be one of the reasons they cannot find patients to get into their trial. The other reasons are they can't find many CC5 patients because few exist and further, apparently one of the trial requirements is that none of their patients have previously used Marivorac (or something like that) which almost all their potential patients have likely tried to use in the past as it is a CC5 drug as well.
Your statement: From TaiMed web....."Phase 1/2 clinical trial of SC and IM injection started in 2012 in Taiwan for HIV positive and HIV negative patients.The current available
UN- AUDITED data show tremendous antivirus activity "
All together studies are done as an adjunct treatment only.
My comment: Correct, Taimed has tested only in combination, with an optimized background therapy (OBT) in phase III. They have not pursued monotherapy as that is pretty unconventional in the HIV space.
Your statement: I exchanged few e-mails in the past with Dr Chen from TaiMed , and according to him they not planning monotherapy for HIV positive patients. Monotherapy they doing study only with HIV negative , high risk patients as a prevention.
My comment: As noted above, monotherapy is a very unconventional, high risk concept in treating HIV patients, so this is why Taimed has not pursued it. If it works for CYDY, it will be a huge win for them and the stock price will go nuts on the upside, but the accepted form of treatment in HIV is to outfox the virus with a variety of therapies. But it has a chance of working since most new HIV patients start out with the CC5 version of the disease.
Your statement: With adjunct phase 3 ( 30 patients total ) they have 36% patients accomplished <50 copies/mil viral load.
If we looking at Pro 140 , even without adjusting the dose 62.5% patients on monotherapy did very well , with many patients <1copy/mill viral load. With adjunct I expect even better.
One patient stop Ibalizumab because developed some immune problems . This is not happening with Pro 140.
My comment: The patients in Ibalizumab's study were very, very sick. So sick that 4 of them died from other causes before the very short trial could be completed. They started with extremely high viral loads and Ibalizumab greatly exceeded the primary endpoint in getting that substantial viral load under control very quickly. Ibalizumab's results were great and no one should think otherwise. That is why it is a Breakthrough Therapy and orphan drug that the FDA clearly likes a lot. PRO 140's results were not for such sick patients so you cannot compare them. PRO 140 may get Breakthrough Therapy but it has not as of yet. To try to convince anyone that PRO 140 is superior to Ibalizumab at this point is not a good idea and the facts don't back that assertion up. It is clear the FDA does not yet think so and they have access to much more info about the trials than we do.
Your statement: For those reasons IMO Pro 140 is superior with CCR5 positive patients.
My comment: Unfortunately, you cannot make that claim yet. We need an apples to apples test and that is what the phase III combo trial is. In fact, PRO 140 needs to beat Ibalizumab's results in its combo trial and it may do that, but we will have to wait and see. EVen if it does, for MDR patients, CC5 patients are likely only about 10% of the total and Iblalizumab works on both CC4 and CC5. With the head start Ibalizumab will have over PRO 140, is it any wonder that CYDY is turning investor attention to monotherapy now? If PRO 140 is not really a whole lot better than Ibalizumab in the maybe 10% of MDR patients who have CC5 tropism, then why will doctors use it? And who would partner with CYDY to sell it to such a small market?
The future for PR 140 is in monotherapy, which is a very high risk/high return situation for investors. If they can be successful there, shareholders might ultimately be handsomely rewarded for the dilution they will need to endure to get there. But it is a high risk gambit.
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