Who else but Bayer would be interested partnering the colon cancer combination trial?
Cydy is not telling BP they're negotiating with Bayer but everybody knows it must be.
Obviously Cydy has no plans to start this colon cancer trial soon.
It's a strategic move. Showing off, telling, what they've got.
Being in talks with Bayer puts even more pressure on other BP to act.
I've tried to make a transcript from yesterdays proactive interview with NP.
May have missed something or made a mistake or two.
If so, I'm sorry, do keep in mind that English is not my mother language. Cheers!
Christine Corrado: “Cytodyn has filed for a phase 2 study with the FDA to treat colon cancer. You have many different indications, talk about the significance of that getting to phase 2 here?”
Nader Pourhassan: “Well, it’s very significant, we have already a phase 2 in (…) metastatic triple negative breast cancer.
And why are we just filing this phase 2 profile, protocol, to with the FDA is because the mechanism of action of this product.
If Leronlimab can stop the metastasis of cancers that has CCR5 on the surface of the cancer cells that means we could be, you know, valid for many of these cancers and we can do a basket trial.
However, we like to get our phase 2 in place, it’ll only costs us about, you know, about less than a 100,000 dollars to get it to this point and instead of spending 100 million from discovery to phase 2. So we like to have this, and our animal studies are very strong, so there is no reason for us not to have a phase 2.
And we perhaps can partner with other companies and all sell each one of these programmes separately (…) “
Christine Corrado: “This combination study, who is running this particular study?”
NP: “Well, doctor John Marshall is a principle investigator but obviously if we’re going to start the phase 2 initiated then we will have other sites open.
What our plan is over here, our BLA submission for HIV can be done hopefully by the end of September. We’ve been talking to the FDA, the FDA got back, they are telling us about the (???), that they want to compare some more results, we have those more results, so we are pretty certain we gonna be filing BLA by the end of September.
So, once we have success we believe our stock will be at much higher level, you know, it could be in the level that people are waiting for and when that happens we will have tremendous amount of funding available to us.
But, lets just assume that the stock does not react as much as we want and let’s just say it goes to 2-3 bucks not 10 bucks and let’s just say that we want to continue with this program.
We also are working very closely with licensing out certain portion of the sales of our product right now. If we can license out the combination therapy and have quite a bit of funding come in that would changes the whole outlook of our company.
And with BLA submission of end of September with monotherapy meeting with FDA (???) around that same time for monotherapy trial and with the triple negative breast cancer readout that is coming out with the CTC reads every 3 weeks or so we could go to FDA with 5 patients if the CTC drops (…) Doctor Massimo Christofanilli (???), pleasantly delighted to meet with him last night at a dinner, indicated “you’re able to go to the FDA” and he will go with us to the FDA to ask for approval if we’re able to do that.
So, with the next four, five months we have so many things coming up together, especially getting a licensing deal done and get the revenue outlook look very clear, we have a project, we have a plan for revenue and it’s gonna be posted to our website from Sirius Health in the next couple of weeks or so.”
CC: “You (???) a study for colon cancer will cost around 100,000 dollar. Are you not concerned about , you know, all these different clinical trials are coming together and placing a burden on the company?”
NP:
“Colon cancer costs us about a 100,000 dollars to file IND and the protocol and have the animal studies and all the other work. Usually costs a 100 million dollars, that’s on the website.
What we gonna do is we gonna receive a green light hopefully to do phase 2 colon cancer and try to partner with other companies who are talking to us right now. They want this programme, they want other programmes.
And we’re going forward to change the outlook of our company, the share price that everybody is getting so, you know, tired, rightfully so, they will see licensing agreement coming in, and we are going to accept one of these licensing agreements.
So, the colon cancer we’re not going to spend another dime till we get those things in place. So, it’s just to show to the world what we have and our focus gonna be our BLA, monotherapy and the CTC readout on the metastatic triple negative breast cancer. We will also be filing NASH phase 2, hopefully soon, (…) which is a very important indication.”
Cydy is not telling BP they're negotiating with Bayer but everybody knows it must be.
Obviously Cydy has no plans to start this colon cancer trial soon.
It's a strategic move. Showing off, telling, what they've got.
Being in talks with Bayer puts even more pressure on other BP to act.
I've tried to make a transcript from yesterdays proactive interview with NP.
May have missed something or made a mistake or two.
If so, I'm sorry, do keep in mind that English is not my mother language. Cheers!
Christine Corrado: “Cytodyn has filed for a phase 2 study with the FDA to treat colon cancer. You have many different indications, talk about the significance of that getting to phase 2 here?”
Nader Pourhassan: “Well, it’s very significant, we have already a phase 2 in (…) metastatic triple negative breast cancer.
And why are we just filing this phase 2 profile, protocol, to with the FDA is because the mechanism of action of this product.
If Leronlimab can stop the metastasis of cancers that has CCR5 on the surface of the cancer cells that means we could be, you know, valid for many of these cancers and we can do a basket trial.
However, we like to get our phase 2 in place, it’ll only costs us about, you know, about less than a 100,000 dollars to get it to this point and instead of spending 100 million from discovery to phase 2. So we like to have this, and our animal studies are very strong, so there is no reason for us not to have a phase 2.
And we perhaps can partner with other companies and all sell each one of these programmes separately (…) “
Christine Corrado: “This combination study, who is running this particular study?”
NP: “Well, doctor John Marshall is a principle investigator but obviously if we’re going to start the phase 2 initiated then we will have other sites open.
What our plan is over here, our BLA submission for HIV can be done hopefully by the end of September. We’ve been talking to the FDA, the FDA got back, they are telling us about the (???), that they want to compare some more results, we have those more results, so we are pretty certain we gonna be filing BLA by the end of September.
So, once we have success we believe our stock will be at much higher level, you know, it could be in the level that people are waiting for and when that happens we will have tremendous amount of funding available to us.
But, lets just assume that the stock does not react as much as we want and let’s just say it goes to 2-3 bucks not 10 bucks and let’s just say that we want to continue with this program.
We also are working very closely with licensing out certain portion of the sales of our product right now. If we can license out the combination therapy and have quite a bit of funding come in that would changes the whole outlook of our company.
And with BLA submission of end of September with monotherapy meeting with FDA (???) around that same time for monotherapy trial and with the triple negative breast cancer readout that is coming out with the CTC reads every 3 weeks or so we could go to FDA with 5 patients if the CTC drops (…) Doctor Massimo Christofanilli (???), pleasantly delighted to meet with him last night at a dinner, indicated “you’re able to go to the FDA” and he will go with us to the FDA to ask for approval if we’re able to do that.
So, with the next four, five months we have so many things coming up together, especially getting a licensing deal done and get the revenue outlook look very clear, we have a project, we have a plan for revenue and it’s gonna be posted to our website from Sirius Health in the next couple of weeks or so.”
CC: “You (???) a study for colon cancer will cost around 100,000 dollar. Are you not concerned about , you know, all these different clinical trials are coming together and placing a burden on the company?”
NP:
“Colon cancer costs us about a 100,000 dollars to file IND and the protocol and have the animal studies and all the other work. Usually costs a 100 million dollars, that’s on the website.
What we gonna do is we gonna receive a green light hopefully to do phase 2 colon cancer and try to partner with other companies who are talking to us right now. They want this programme, they want other programmes.
And we’re going forward to change the outlook of our company, the share price that everybody is getting so, you know, tired, rightfully so, they will see licensing agreement coming in, and we are going to accept one of these licensing agreements.
So, the colon cancer we’re not going to spend another dime till we get those things in place. So, it’s just to show to the world what we have and our focus gonna be our BLA, monotherapy and the CTC readout on the metastatic triple negative breast cancer. We will also be filing NASH phase 2, hopefully soon, (…) which is a very important indication.”
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