Replies to post #11223 on Cytodyn Inc (CYDY)

[KobeF]

So we will know in a couple of months whether or not this is a scam?!

[KobeF]

Forgot to mention the company's financial structure and warrants are purely disaster to the current shareholders.

[pearsby09]

According to the graph on my post..there is not an extremely strong correlation between BTD and approval (historically)...but I am sure it wouldn't hurt in fact, a feather in our cap with BTD. The BTD designation will not determine approval or non approval..80 plus% BTD went on to get approval..However. several drugs without BTD eventually gained approval. so everyone be very careful..one way or another.

[trding]

Why everybody think BTD is such a big deal? If BTD is granted, SP might jump up 30-40% and then back down.

From CC

Unidentified Analyst

Thank you very much. And follow up real quick is you are saying the BLA submission could be as early as -- early part of Q2, if we do get this primary efficacy follow up from the 30 patients, what is your feelings and the strength of the BLA going in discussion with the FDA? Thank you.

Dr. Nader Pourhassan

Yeah. Very good question again. Yes, with Biologic License Application, we believe if we get breakthrough designation our CMC package could be prepared faster. There could be other advantages. FDA has told us to enroll all 30 patients and come back and let’s talk about the BLA. So having a breakthrough designation and going back would be very big plus for us. We would report as things come up. Next question?

IMO primary enrollment completion will start the buying pressure because it starts the countdown to results

Timeline

Yes. Hello. I just have a quick question regarding P3 combo. I know we only have 12 enrolled and your anticipation as we can get the other 18 enrolled in Q1 along with primary efficacy point, which is the one we follow-up? Why are you so optimistic about getting 18 when it’s taken so long to get the first 12 of that in all respectfully? Thank you.

Dr. Nader Pourhassan

No. Very good question actually. Thank you. When we first started this trial we immediately stopped our processes as we were enrolling hospitals and then back to FDA and asked instead of having three drug resistance let us have two drug resistance, that process when you send a letter it takes 30 days waiting and then you get it and you have to train all the sites again. Then we went back to FDA say let us have one drug resistance and when you go through all of these processes it took us about a year, doing all of these and as we got where we need to get, which is reduce number, during this one year we enrolled 38 sites and hospitals.

Now if you check with any institute or any CRO, enrolling hospital, two or three per month or maybe four or five per month is a lot. So we were working on getting the hospital situated and now they are very excited and they are able to find the patient. And the fact that we have 13 patients in the screening and these 38 hospitals just need to give us one patient per hospital and that’s 38, not counting the 13 in the screening.

We talked to our senior clinical person and he is very optimistic that we can have this. Obviously, we are not saying that this is 100%. We need to see how it folds out. But it’s very positive and we went through Thanksgiving and Christmas and we still enrolled. So I think these numbers are very exciting and we are going to be able to have our primary endpoint first quarter as we have said before.

Unidentified Analyst

I have a follow up to the last question, which is what are the possibilities of raising non-dilutive capital such as from the National Health Service, CDC, DOD, philanthropic the activity is because as you know HIV/AIDS is one of the most well-funded philanthropic medical areas in the world and this is the science and why we have stayed with the company so long is because we believe in the science and the medicine and the hope for humanity in United States and around the world. But as you know the stock market is an emprise indicator of the company’s real worth but the last two raises had very detrimental effect on the stock price coming at by more than half from the top where it sits now. So have you explored non-dilutive financing from any foundation, agency, governmental body or anybody?

Dr. Nader Pourhassan

So thank you for your question. In past we had been beneficiary of $28 -- almost $28 million worth of grant from NIH. Progenics used those grant and the pace that they were going forward was really very, very slow. We definitely welcome any opportunities, but we believe it is to our best of our shareholder and our future of our stock to get these products immediately to primary endpoint and hopefully to approval. That would be very valuable to everybody and if we were going to spend few years to raise money from these places or not raise money to receive grants from them, I think that would be very time consuming and the fact that we had that experienced before, because we just need to go as fast as we can.