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If approved maybe used off label as monotherapy.
It is not at all uncommon for drugs approved for one indication to be used off label for other indications.
So if PRO 140 is approved for use in combination with HAART drugs, and users come to learn PRO 140 is being used successfully as a monotherapy in an ongoing clinical trial, the chances are good that many will choose to use PRO 140 off label as monotherapy.
Saltz:
Tony is so confident in the success of PRO 140 that he recently invested $1 million of his own money in a current raise.
If, as some have said, management knows better than anyone what is happening with the ongoing trials, we should all feel confident in the success of PRO 140, and the prospects for Cytodyn.
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.
Mr. Pearsby:
You are continuing to miss the point regarding PRO 140.
Yes, HAART drugs work, and help suppress viral load, although most suffer from resistance over time.
However, the problem with HAART drugs,in addition to resistance over time, is that they have toxic side effects.
Read the label of any HAART drug, and you will see a very long list of side effects, and possible toxicities.
As with HAART drugs, PRO 140 also suppresses viral load.
However, unlike HAART drugs, PRO 140 suppresses viral load without any toxicity or side effects, other than minor discomfort at the injection site.
This is a HUGE advantage that PRO 140 has over all HAART drugs.
If the Phase II and IIB results for PRO 140 are borne out in the ongoing Phase III pivotal monotherapy trial, and gets FDA approval for this indication, PRO 140 will likely become the standard of care in a multi-billion dollar industry for HIV drugs.
In that event, Cytodyn will be worth many times more than its current value.
In the meantime, Cytodyn's likely approval for use of PRO 140 in combination with failed HAART drugs, which is late in that study, should enhance interest in Cytodyn from both investors and possible suitors.
Finally, I think many would appreciate it if you would finally come clean about your agenda, and an admission that you are short, rather than long, the stock.
LM
Share price is ridiculously cheap for a drug about to enter Phase 3, with a solid history of safety and efficacy.
The board clearly disagrees with the positive assessment some here have regarding Pourhassan, which is why he was demoted. As a significant shareholder, I will continue to lobby for his ouster which I believe would be for the betterment of the company and its shareholders. Those who disagree are of course free to voice their support. Regardless, I remain confident in the company under the guidance of Tony C.
Prior to investing substantial sums of money in a number of Cytodyn private placements, I spoke at length with both Dr.
Burger and Pourhassan. I also did extensive research on both men, as well as PR0 140. I chose to invest in Cytodyn, in large part, because of Dr. Burger, and in spite of my lack of confidence in Pourhassan.
Over the years, I have followed Cytodyn closely. I have listened to every conference call, including those hosted by Pourhassan, and read the transcripts of every transcribed call.
In short, I am a serious and substantial investor in the company, and consider myself to be knowledgeable about management.
It is based upon such knowledge, and my sizable investment in the company, that I have urged the company to terminate Pourhassan as I continue to believe he lacks the background, qualifications, or experience to manage a clinical stage biopharmaceutical company such as Cytodyn.
I was grateful the board chose to install Tony C as the top executive. I will be more grateful when Pourhassan is terminated as I don't want any more of the company's
minimal resources to be paid to him.
Nor do I think Pourhassan has any commitment to Cytodyn beyond collecting a hefty paycheck. Otherwise, he would have done as Tony C did, and purchased stock at today's depressed price.
You have a right to disagree. That's what is great about this country.
However, if you think with your wallet, instead of your heart, you will probably agree with my analysis.
Whether you agree with me or not, I wish you the best of luck with your horses, health, and investments, although not necessarily in that order.
Lawman
Dr. Burger stated in last cc that he was confident company would get BTD for both HIV and Retts. If Dr. Burger is right, this would be very big news.
Absolutely right, Bobby.
One more to purge.
I could not agree more, Kobe. It is a waste of valuable company resources to keep Pourhassan on the payroll.
Give the company credit for finally replacing Pourhassan with someone in Tony C who has the background, competence, and experience to move the company forward. Yes, Pourhassan was a disaster, and yes he caused such distrust that the share price plummeted to historically low levels. However, I am confident Tony C can right the ship, and with it restore shareholder confidence that was lost while Pourhassan was running the show.
I could not agree more. Pourhassan does not present well, and should never be allowed to speak in public on behalf of the company. Either Dr. Burger or Tony C. should make all of the presentations on behalf of the company from this point on.
Pourhassan has been very well paid for his incompetent years of service without using any of that money to purchase shares. Hopefully, Tony C. can dig out of the mess Pourhassan created.
Heck yes, I am disgruntled.
Aren't you?
Watching the share price dwindle, snd having promises made and broken for years will do that.
I am pleased that someone competent is now running the show.
However, Pourhassan has being paid far too much for doing far too little, and should be terminated immediately IMHO.
If Pourhassan was still running the show, the company would likely be bankrupt, or well on the way to insolvency.
There was a reason the board put Tony in charge, and it wasn't because they thought Pourhassan was the right man for the job.
Pourhassan lacks the knowledge, background or experience to run any company, much less a clinical stage biopharma that requires qualities Tony C. possesses, and Pourhassan does not.
You may choose to use the company's limited resources to pay someone who adds nothing to its value, and who has chosen not to invest any of his own money, as we have all done. However, my vote is to use the company's resources on people who can help it advance towards commercial success, and that person is clearly not "Dr." Pourhassan.
Tony C knows has the experience and savvy to bolster investor confidence. Not only in the way he presents on investor calls, but putting some skin in the game. The more Tony does, and the less Pourhassan does, the better we all will be.
Speaking of Pourhassan, his lame excuse of not buying stock because he was prohibited from doing so has now been exposed as a falsity. The company's precious resources should not be wasted on paying this guy's salary.
MTNB has far more activity on Stock Twits.
I agree that good things are ahead for MTNB with the results of two Phase II clinical trials for encochleated amphotericin B to be announced in June. If the results are good, as I expect they will be, the company will likely be on the radar of a number of big pharma companies either to license MTNB's patented encochleation process for their own toxic but effective drugs, or to invest in or buy out Matinas while it still has a low market cap.
Exciting times are ahead for Matinas.
Daily sp machinations mean little in grand scheme of things.
In the end, it always has been, and always will be, about the data.
If the data in the ongoing Phase III trials is good, the sp will go up.
If the data is bad, we won't need to worry about the sp as there will be no company to have a sp for.
While slow in coming, we should have data soon.
We will then know if we have a winner or a loser, and the sp will follow.
I, for one, don't think Tony C would be so heavily involved in a company if he viewed it as a losing proposition.
LM
I like Dr Burger, and don't mean to sound skeptical, but if he thinks CYDY will be a $16 stock, why isn't he buying shares hand over fist?
I hope Dr. B is right because if he is many people on this board, myself included, are going to be VERY happy.
LM
Reversion of two patients disappointing but not fatal.
If the scaffold is approved by the FDA in early 2018, as the company expects, NVIV will have only FDA approved device for treatment of SCI that has achieved positive results in a still much higher than typical percentage of the SCI population.
In addition, a clinical study for the much larger cervical SCI population has been approved, and will be soon starting, in Canada. If successful, that could greatly expand the use of the scaffold.
Down the road, the scaffold will be seeded with stem cells that should make it much more effective.
There will be blood on the streets of In Vivo tomorrow, which is the time for those with conviction and cojones to buy.
LM
Agree completely Saltz.
Yesterday was needed on many levels.
First, to establish that a new competent leader is in charge.
Second, to present a candid assessment of where the company is now, and where it will be going in the future.
With competent management now in place, I am much more confident in the prospects for Cytodyn that I was before the CC.
LM
Agree with you again Saltz.
There is clearly a new sheriff in town, and order is quickly being restored.
I am much more optimistic now than I was before the CC.
LM
You are right Saltz.
I asked Dr. Burger about BTD in today's call, and he was clear that it would be granted.
Pourhassan messed up the BTD application, but with new management in place, they will make sure such mistakes don't happen in the future.
LM
I agree with you 100% Saltz.
I finally think we are on the right path with the right person at the helm.
I doubt it, 123.
However, I feel better with Tony now running the show.
LM
I thought the CC went well.
The most important part of the call to me was learning that Tony C. is now firmly in charge, and Pourhassan has been relegated to a subservient position.
I have confidence in Tony C. being able to lead this company, whereas I had (and have) no confidence in Pourhassan.
Tony C. was well-spoken, and gave investors the straight facts. While some of the facts were less than what was hoped for, such as the need for $60M+ in financing, denial of BTD, and a delay in filling the Phase III combo trial, other information provided was encouraging.
For one thing, Dr. Burger said he was confident in getting BTD for PRO-140. I have spoken to Dr. Burger in the past, and found him to be both highly knowledgeable, and a straight shooter.
In addition, Tony C. intimated (as much as he was able to do so) that he was confident in approval of PRO-140, both in combination with other HAART drugs, and as monotherapy.
Although that too was Pourhassan's party line, coming from someone with Tony C.'s background and experience makes it more credible.
The bottom line for me is that this company is now being led by a pro, instead of an amateur, and this pro knows how to get clinical stage drugs such as PRO-140 approved by the FDA.
Yes, Tony will have to clean up Pourhassan's mess. And yes, Pourhassan left investors with a bad taste in their mouths from his past missed projections, and other bad decisions.
However, in the end, PRO-140 either works, or it doesn't. And I am confident we now have the right person in charge who gives us the best chance of getting this monoclonal antibody across the finish line.
LM
Whatever the reason for the denied ODD, M143, it is another miscalculation by management.
I am hoping we have had the last of such screw-ups by our current CEO, and we will have a changing of the guard tomorrow.
My guess, A17, is that Pourhassan hoped to get ODD for GVHD.
It appears, however, that the application to the FDA was not presented that way.
Another botched FDA application that can be laid at the feet of the esteemed "Dr." Pourhassan.
Hopefully, we have heard the last of the good doctor as he hands over the reigns to Tony C.
LM
I agree Chump.
In the past, however, even cordial questions, that did not suit Pourhassan's overly optimistic agenda, were met with scorn and disdain.
I am hoping Tony C. handles tomorrow's call, and presents a professional and realistic assessment of the company's plan going forward.
If Pourhassan presides over the call, many shareholders will no doubt be extremely disappointed.
LM
Grip:
I guess we will have a better idea when we see who presides over tomorrow's call. I sure as heck hope you are right about Tony C. supplanting Pourhassan.
This company is crying out for someone new at the helm who has the knowledge, background, and experience to lead this company towards approval and commercialization of PRO-140.
Let's check back tomorrow after the call.
LM
Anyone has explanation for today's 16% pop?
If denial of ODD is good, why apply in first place?
At best, this was another miscalculation, and waste of valuable resources, by management.
The question for this company is whether its very good technology can overcome its very bad management.
More and more it is becoming painfully obvious that this job is much too big for Pourhassan, and we need someone with biopharma experience leading this company.
Oh Pear, you are dead wrong.
If half of the people on HAART (which itself has resistance issues, or what you refer to as "rebound") can successfully maintain a low viral load on a non toxic monoclonal antibody, PRO-140 will be a blockbuster.
Think of it; half of the HIV patients on PRO-140 would mean that more HIV patients were taking PRO-140 than any other HARRT drug or drug cocktail.
If that is what you consider to be a failure, then you must think Tom Brady and the New England Patriots are failures as well.
LM
Shane should join Kelly on the board.
Kelly and his wife hold $2M shares, and he became a Cytodyn director.
Shane and his wife hold $1.5M shares.
Ergo, Shane can become a Cytodyn director should he choose to ask.
What about it Shane?
We on this message board can sure use some input, not to mention eyes and ears, on the board of directors.
And what about the Shiek with his millions of shares.
Perhaps Shane can suggest to Shiek that they both join the Cytodyn board.
Shane?
LM
Boomer nailed it regarding Pourhassan.
Absolutely spot on analysis.
You cannot have a successful clinical stage biopharma unless you have a highly competent and FDA experienced CEO at the helm.
Pourhassan is in way over his head, and has neither the background nor the experience to successfully guide this company.
Announcement regarding Pourhassan.
Other than positive new clinical data, or BTD, the best announcement we could hope to get in the upcoming CC is that Pourhassan is being replaced with a competent CEO.
If such an announcement were to be made, I anticipate we would get a big bump in the share price.
LM
Dolph:
In reducing the N to 30 for Cytodyn, the FDA followed the protocol agreed upon for another clinical stage biopharma with a monoclonal antibody for treatment of HIV.
Right place, right time.
Defend Pourhassan if you wish, but do so at your (and mine) own financial peril.
LM
Wally:
I've got to respectfully disagree with you regarding Pourhassan.
It is never too late to right the corporate ship by getting rid of executives who are incompetent, and replacing them with seasoned professionals who have a strong track record of success.
I have heard of many companies where new management was able to turn the company's fortunes around relatively quickly.
If Pourhassan remains as CEO, a turnaround is far less likely than if a competent CEO is brought in now.
Listen, I am very heavy into this name, having participated in two Paulson private placements.
I have also spoken to Pourhassan, and listened intently to all of his conference calls.
I am calling for Pourhassan's ouster because I want Cytodyn to be successful.
Let's hope at the very least that someone other than Pourhassan moderates the next investor call on April 18.
After that, let's hope he is replaced, and soon.
Best of luck to everyone.
LM
Chump:
Best of luck to us all, with or without Pourhassan.
LM