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How the drug works
A repost of mine
Cancer cells never get the signal to die like normal cells do...they just keep multiplying......something they do at a faster rate than normal cells which makes them starved for oxygen. Oxygen starved cells become anaerobic and thus puts them into acidosis (acidic). They change to live like this...makes them a mean tough cell. So their ph is below 7 while normal cells are around 7.2
The PVCT group decided to try to target cancer to take advantage of this difference. Why not others? For years we had squeeze bottle mustard but glass bottle ketchup until someone saw the answer that was right under their nose....But I digress...
For whatever reason the targeting of cancer was under everybody's nose. Then PVCT had a "Ureka!" moment....target the ph difference and so they set to work. They set down to design a small molecule to bounce off normal cells and go into the lower ph cancer cells. They put together different atoms on the computer and ran simulations based on the ionic properties that should work. When they found a candidate that worked in the simulation they realized it already existed as an eye dye...Rose Bengal. They filed the patents the very next day.
Now why does pv-10 kill cancer? Well, in every cell there is a sub cell that is called a lysosome. It is very acidic. It's normal job is to chop up bits food for the cell to use...like a stomach. When a cell had divided enough times the nucleus sends a signal out and tells the lysosome to self destruct...thus spilling out its very acidic contents and killing the cell from the inside out. Cancer cells never give that signal for self destruction. Here is where pv-10 comes in. Due to the molecule's design it is attracted to acidic (negative charge) cells. Once in the cell it gets absorbed into the lysosome to the point of rupture. Thus causing cell death. Since most cancers are acidic....pv-10 will work on most cancers while sparing normal cells.
In fact any excess is processed out of the body and into the bile in about an hour.
The very nature of how it targets and why its safe is basic chemistry. Other drugs are trying to induce the cell death signal or target single antigens found on the cancer cells surface. None have done so without damaging some normal tissue.....thus side effects.
The bystander effect works because the cell dies from the inside out leaving the outside antigen markers intact. The immune system does not recognize bad cells or foreign invaders...too complicated.... But rather it recognizes what is not self. Everybody has cancer but in most cases the immune system uses dendritic cells and apc cells to identify those cells which have changed enough to no longer resemble a normal cell. Some cancers develop a cloaking mechanism that keeps the dc and apc cells from reading the change in antigens on the cell surface. When Pv-10 kills the cancer cells from the inside out it stops the cloaking mechanism and allows the immune system to read the difference in self on the surface. The immune system then picks out the strange antigen markers and tells the T cells to go looking for those cells who have that difference. T cells are not fooled by cloaking tricks and go hunting that type of cancer and kill it.
Single antigen targeting is tricky. It's like going into a room with people wearing a red bandana and saying your going to target red bandanas wearers. Sometimes good and bad people wear red bandanas so your targeting is incomplete. But if you know by experience that if good people wear red bandanas around their necks and bad people wear then around their head you have a context to determine good and bad. So by letting the immune system read the antigens in context of where they are placed you allow it to zero in on just bad cells.
Pv-10 does not target antigens but rather allows the immune system pick the antigens it finds as being different in context of the cell surface. Mother Nature knows better than we do on targeting once giving the chance.
PV-10 kills cancer and spares normal tissue by a very simple process. The fact it is also a dye has nothing to do with nothing. Many other drugs came from dyes....look that up.
In the news section of the blog in the top news article... In about the middle of the article you will see a screen shot of where his post on twitter is deleted.
I have read many comments by AF that are now deleted from his twitter. Someone I guess has been copying his posts and caught one example and sent it to Dominic.
From the latest news on my TD Ameritrade app: the Rosen Law Firm says the deadline for being lead plaintiff is July 28th. And as of now "No class has yet been certified".
Bye bye.
Institutional Buying
I have heard that there has been some institutional buying, more than the online reports show. So I have done some research and found this link: http://en.wikipedia.org/wiki/Dark_liquidity
Now if I was an institutional that was accumulating then dark pools sound like a smart strategy. Showing your hand while accumulating would drive the price up. I have no proof that this is what has been happening but I cannot dismiss the logic of it.
Various Factors Affecting Stock Price:
*Peter spends a bunch of his money exercising options
*Adam F caught deleting key tweets.....law firms have Adam as key witness....which means key support for lawsuits just got knocked away.
*Big pharmas buying smaller pharmas
*Market feeling that PVCT might have a regional deal in the works.
*Starting the PIII soon.
To me it feels that PVCT is finally pulling itself out of the quicksand in stepped into.....and people that have that same feeling might be buying.
On May 15th the updated website said "PV-10, A breakthrough cancer drug". On May 19th it was changed to "breakthrough seeking cancer drug" and finally on May 20th it was changed to "an Investigational drug for cancer"
The web designer probably thought the first iteration fit the idea that the drug was a breakthrough in innovation.....though I am not certain. Personally there is zero wrong with calling it a "breakthrough cancer drug", it is. They did not say BTD approved drug. The designation was changed after someone likely noted it probably was a bit too close to the wording for BTD. One day later the word was eliminated altogether.....personally I would have never changed it to begin with. Recently another pharma said the exact same thing in a PR.
Be that as it may be. The web site had the word breakthrough in its wording for four days. Now it is up to the lawyers to PROVE that the stock dropped because of the wording. Something that I think is unlikely to happen. And those that could have been affected by the change are only those that bought between May 15th (and the hour the website was changed) and May 19th. Obviously those that bought before that date saw no such wording. And changing the wording to "Investigational" would have to be proven to cause the stock to drop. Furthermore, any plaintiff that stayed in past the 20th cannot use the word change as an argument.
The law firms have bupkiss.....nothing that I can see.
Look at the Blog's news section.
Supreme Court ruled that in class action lawsuits where the plaintiffs are seeking compensation for the stock drop.....that it is up to the plaintiffs to PROVE that the companies action caused the stock drop. Such proof does not exist and these lawsuits (having no lead plaintiffs I imagine) will go away with zero cost to the company.
The Supreme Court has now made it very hard to bring class action suits against companies in this manner.
The stock is steady....it is trading almost a million shares. May only guess is that if there is constant selling in this range then they will buy at this range. Another thing to consider is that they have to report ownership to the SEC past 4.99%.....maybe they reached that point. This is only a guess since I have not heard anymore out of NYC.
And THERE YOU HAVE IT!.....Why a PIII has taken so long. PFS is the old FDA standard endpoint and why it is not really appropriate for new drugs like PV-10 that are treating tumors on a one on one basis. The FDA wants a Square peg in a round hole. It is also one of the reasons PVCT went with the BTD route because the endpoint was the correct one........finally. Aaaaaaaaaaaaaaaand.....then the FDA changed the BTD rules mid May....the same time they were making the decision on PVCT.
Now is everybody clear?
Now I will try to find your answer for you. Might take four years.
Yes....it's been going on for too long it seems. What makes me think that they are coming? The company pr's say so.....the second Pfizer guy with a team going India for PVCT says so....Pete said so on the CC.
Does the delays make you want to pull your hair out?....yes.
I expect one day to get a pr about a deal out of the blue when we least expect it.
But don't base your investment strategy on this one possible event.
Your right in a sense. It takes two mm selling back and forth to each other for less and less to walk it down.....but EDGX stepped in to buy and keep it where it was.
Because based on my experience that is how you walk the price down....100 shares at a time. But I was watching EDGX on the buy side mopping them up. I am not 100% certain but this is how I am seeing it.
Usually when the trading slows to a trickle you can walk the stock up and down with 100 share trades.
What it seems is going on.
I am studying the level two. You have 100 share blocks trading back and forth between two market makers to try to walk the price down.....but you have one market maker buying them up to keep that from happening. It appears that EDGX is the market maker for PVCT. Cantor was the MM on the OTC towards the end for the purpose of steadying the stock for uplisting. Since the uplisting I have been watching EDGX closely and have determined that their behavior indicates that they are the new MM for PVCT with the purpose of keeping an orderly market.
What this means to me is that if there were any shorts out there then they already shot all their ammo....it also means that buyers are sitting on the sidelines to see if this is the bottom. The possible short players got another law firm to jump in to the baseless suits in an attempt to stir up selling....to no avail.
If....and I mean a wild ass guess "if"......if the shorts haven't covered and they announce an India deal soon (which means all the money needed to get PV-10 to the end) then we have the perfect storm for a short squeeze of epic proportions.
Things look interesting again.....time to break out the popcorn once more.
The findings in PII mirrored that of PI. The findings in Moffitt mirrored the PII. The findings in the Cup program are the same likewise. And everything mirrors the murine models as well. I think it is safe to say what is to be expected. The results are highly repeatable. Now designing the study with that in mind and I think 210 patients will be just fine. I am expecting a bit better results since they are going to be treating all the tumors. But I am not here to convince you to buy or sell but just to provide info and my views.
I understand your concerns.
Read the Blog via the links below and let me know what you think after that.
http://provectuspharmaceuticalsinc.blogspot.com/2014/06/trial-math-meeting-primary-endpoint-pt-1.html
http://provectuspharmaceuticalsinc.blogspot.com/p/news.html
BTW....the above links to the latest posts of the CTD Blog just destroyed the major argument in the latest hit piece.
Dom's Kung Fu is stronger than the Tolietstopper.
No it is not. The trial design was well thought out. The writers point on sample size was it was half of some. But those "other drug sample sizes" were half of others.
The sample size depends on what the efficacy is.
The better the drug works the less of a sample you need... provided it is safe.
But if you have a drug that only works a bit better than the comparator you have to have a much larger sample size to make sure your data is not random fluctuations. The writer kindly overlooked that or is just ignorant on statistics.
There is plenty of money to reach the midpoint.
They will need more to go past mid point.
The writer is not a doctor or a statistician or a very good detective.
He is a trader that writes hit pieces.... And this makes him an expert in oncology and trial design how?
Go read the connecting the dots blog on the trial design... You will get a real education there.
After tax income is not as high as you think.
Their pay should be in line with other mgt and medical doctors.
They can make more salary working for big Pharma... In fact they have had those offers....remember three of them are top in their field....they invent drugs.... Highly valuable skills. They invented a drug for cancer and you want to pay them the same as a doctor who sticks a thermometer up your butt?
What they do with their pay is not our business.
And considering the crap they take from shareholders and the bashers and the FDA, I would consider them underpaid at this moment.... I sure the heck would not want to be in their shoes right now dealing with all this. And if they feel under appreciated they can always throw in the towel, go work for big Pharma, and your stock goes to zero.
So I see it as a fine line I don't want to cross.
I understand your concerns.... And the reasons for them. But I look from another point of view. These guys hold the key to our future earnings in this stock and they already got spanked for taking a larger salary. You may not earn in your field what they do but that does not mean they don't earn it.
They came up with the drug.... And even after a full pIII it will be about a billion less in development cost than the typical drug. It's a cheap drug to make.... The competitors drugs cost over $100,000 a treatment.
What they did to earn that money is amazing once you look at it all.
Your concerned by a writer who admits he is short and writes a hit piece. He has motive to bash. He has no medical experience if you listen to him. He has no statistical background which is apparent when he tries to use other drug trial examples. The weaker your drug works the more patients you enroll to find significance. He's a trader grasping at straws to cover his short. It is a hit piece full of innuendos with no basis of truth. He exaggerated the pay to mgt over four years by a lot. It's completely ridiculous. And to hide from retribution he hides his real name.....that's true journalism?
If any of you let this hit piece unnerve you.... Then it's best you move on.
I, for one, consider it funny as hell.
New CTD Blog
Two on front page
Tom123 TA is right...again...my hats off to you.
Amazing.
New CTD Blog
http://provectuspharmaceuticalsinc.blogspot.com/p/news.html
What I like in the nitty gritty details is that China and India may be copying PVCT's PIII trial design and running one of their own. This should accelerate the enrollment.
Sometimes
CTD is working on a blog on how china and India trials will fit in to Pvct PIII
Stay tuned as this develops
They have insurance for those lawsuits if need be. I am expecting them to go away though.....there is nothing they did wrong.
The endpoints are standard PIII endpoints so they are safe to use them. The chemo comparator is used instead of a placebo. A proper comparator would be an approved red injectible drug but no other exists. The FDA did not want to fool around with the complications of the bystander effect (something the FDA is not ready for yet) so they have instructed them to treat all the lesions.......something that should produce very good data.
They are not out of touch with the FDA....rather, the FDA has a system in place that is out of date for these new types of drugs. How do you measure progression when the tumor goes away quick? How do you measure pain response where there is none? The number zero does not work well in statistical equations. The tried and true FDA PIII's always assumed the patient might get better by a percentage.
Remember this is a whole new way of treating cancer.
I contacted someone up in NYC to see if there is institutional buying today. They said at least one is but they would not say the volume.
Yup
Nice to see it
Shorters tried again today to no avail
I did not attend
But from others there:
All measures passed
No q&a until the cc
Mgt seemed to be in high spirits
But that was from others who attended
email me your email
I'll send it over to you
vorlon1966@yahoo.com
Beats me why it does not show up....it's a five page document. If it is a fake it is a very clever one.
Maybe it is only for their clients....who knows....
Go to yahoo...they talk about it there.
Others have it but I don't want to risk publishing copyright stuff.
Anybody else here get it?
Sent to me as a pdf from a Schwab subscriber.....can I legally repost here?
What changes charts? Intentional actions for one. What you are looking at is a controlled price and no shares available to short in my opinion. New actions and reactions create new charts. I think this week we get to see this chart evolve.
Charles Schwab issues OUTPERFORM on PVCT!
Finally!
9:50 this morning!
And so it begins.....
What happens if they announce a regional deal with large cash upfront money this week? They did say they are going to talk about it....they would not do so without something there.
The mm gaped it high and then sank it in pre-market to give impression it was going down fast. This was just a shorter's faint....it failed. Like Friday it will hover between 1.20-1.30 as that is the bottom set by the bear trappers. And remember there are almost no more shares to short....the institutions do not put PVCT on margin.
If PVCT gets an MOU from India or China or both then it is game over for shorters since all necessary money for multiple PIII's will be there.
They did raid us but their selling got absorbed. Not all bear raids are successful. There was a group out there ready to buy up all the selling....someone who is already in.
Some things to factor in....
If my sources are correct and Institutionals bought in big
That would explain much of the weeks volume
It also explains lack of shares available to short
In order to see if this is all true we would expect good support and lack of shares to short to continue
Did you notice the sideways action last half of the day?
That was tight control accumulation
The bear trap was something to watch
The mm allowed it to drop to get the bears to sell then they sucked up every share and raised it
I almost cried it was so beautiful.