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From my web of info
Institutional bear trap
Big group decided to teach Shorters a lesson
If they try to short it again they will burn....again
Score one for our side
Someone very big is in
They don't want their stock messed with
Feel free to sticky post anything I post you feel important.
How the drug works
My replies on the bash article
and I really think the History of dyes and drugs link is very important.
More innovation.
Replace the iodine in the RB molecule with Iodine-124 and you have positron emitting pv-10. Why is this important? Inject it into the blood stream and wait 12 hours and only the cancer retains the pv-10 while the rest is gone from the body. Now get a pet scan and detect cancer down to one cell.
PVCT patented that.
The link below shows I-124 as a pet scan diagnostic.
http://pubs.acs.org/doi/abs/10.1021/mp100358f
Patents protect ideas. In this case the idea is combining RB in a saline solution for use as a cancer treatment. It is well protected. In addition it has orphan drug status which is enforced by the FDA. That means no lawyers need to be involved in patent suits. If PVCT finds a company copying them then one phone call to the FDA brings the wrath of the federal government down on the copiers.....immediate shutdown.
Now lets talk about commercial RB already out there for staining corneal scratches and marking the liver. It is 95% pure....not high enough for oncology use by international standards. PVCT invented the process to make RB 99.9% pure....they own those patents.
What about similar molecules that could do the same thing?.....already thought up, mapped out and patented by PVCT. Nobody can invent anything close to this molecule that PVCT doesn't already own the patents on.
They have strong Kung Fu on drug innovation and patent protection.
I have no info.
But maybe by having the CC after hours allows more time for discussion.
An interesting read....
http://www.cbmh.ca/index.php/cbmh/article/view/40/39
It is the history of Dyes and Drugs.
I am thinking that.
How the drug works
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 receptors found on the cancer cells surface. None have done so without damaging some normal tissue.....thus side effects.
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
Ok.....I'll go over a few.
Yes the high tech lab equipment is housed in a commercial metal building (not a barn)....I fail to see how brick walls or a fancy fountain would make things run better.
A long time ago there was a company called Photogen where the founders of PVCT used lasers in cancer research. Photogen came into existence by reversing in to a purchased Nasdaq shell corporation called MT Financial Group. A few years into Photogen the founders of PVCT discovered PV-10 and they proposed to change the direction of the company. The major shareholders at that time wished to continue with diagnostic products the company had. There was a rift and PVCT mgt left Photogen with the PV-10 patents and started PVCT. Photogen, now being RUN by OTHERS, changed the name to Imcor and ran the company into the ground. PVCT mgt had zero to do with that.
The company is not tied to any paid stock promoters....that was a lie.
The patents that are due to run out have to deal with outdated technologies not related to PV-10. PV-10 is patent protected to 2031.
They did pay consultants as all companies do...a lot of work is done by independent labs and experts.
They did raise money as all companies with no income do.
They did pay themselves.....more than some were comfortable with.
The drug is derived from RB which is a red dye used in medicine and has other commercial uses....so what? One of the first antibiotics came from a dye....google that. Most drugs come by accident from some pretty strange sources.....bread mold? Imagine trying to pass penicillin today with AF flaying his hands above his head saying bread mold cures nothing....blah...blah....blah.
What makes RB so unique is it just so happens to have the right molecular configuration that allows it to be attracted to negative charged ions in acid cells.
I want valid points numbered and listed here on this site.
First....those sites are useless....they can and do hide their ownership. Second....evidence as seen by the trading patterns. Watch the level two alongside of time and sales.
Was there a hit piece out today?.....yawn.....
Weak hands have been out for awhile and institutional ownership is up....so these hot winded articles have no more effect than a fart in a whirlwind. AF is now feeling the karma of irrelevance.
Now it is time to close the bear trap....take it up.
Another indicator is the lack of bashing on Yahoo. Usually there is high volume of bashing but it's pretty quiet right now. They are letting it rise. Now Tom123 can tell us where that next support position might be that they will try to drive it to. The short raiders use TA against us. By reinforcing TA key points they set up the regular traders to be easily pushed at those key levels.
The volume is way to high.....the rise is way to fast.....be prepared.
The good and bad of trailing stop loss orders.
If there is a real short attack that is successful then the trailing stop loss order would help.
If the market makers decide to drive up the stock they may spike it down to steal your shares before moving up.
Watch for twitter talk and AF tweets to get an idea when they execute a raid. If you plan on staying long like me then don't worry about it.
As the institutions gather more shares...and they are....the attacks become less and less effective.
It is my understanding that AF will be using the opinions of a doctor that is on the board of ONCS. Pretty ballsy of that doctor going up against Webber, Moffitt et.al. I would think it would be a big blotch on his career to do so....but then again...AF would stop at nothing to attack this company. It has become something personal like Ahab and Moby Dick. It would be better to start referring Adam as Captain Ahab.
No....I don't think so. I think this is manipulation to pull in the momentum buyers who are the stupid ones that buy on rapid rises. When there is enough momentum moving up then AF et.al. will be short selling into it.....followed by the hit piece.
If history is an indicator along with tweets and machismo from the dark side then it is the proverbial pre-AF hit piece rise.
Brace for the bear raid.
Who knows? That or one dumb writer.....maybe both!
The Motley Fool wrote this ten days ago:
http://www.fool.com/investing/general/2014/05/30/why-wall-street-hates-idenix-pharmaceuticals-inc.aspx
Today we have this:
http://www.usatoday.com/story/money/business/2014/06/09/merck-identix/10223071/
Just goes to show you that dumb tech writers do not know the pharma industry.
Oh....lol
Doing DD does not require being intimate with anything
Simply think up your questions or hypothesis and then google it
You would be amazed at what you find
http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5728
Also, spend hours on the FDA site
Read it and reread it
Then think about what they are saying
You will start to get the hang of what I do
Then if you have a question you can't answer
Contact someone who might know
All the way to the end of a pIII?
Could be.
PIII data will be monitored by an independent group.
A few months into the study they will peak at the data.
If Pv-10 blows the comparator out of the water though, the monitoring group can recommend immediate stop of the study and recommend it proceed to the nda.
If it goes to the intermediate point and the data looks good then historically that is where big pharmas step up and take out the company.
Lots of ifs, ands or buts.
Do your own dd to confirm
Btd is not really killed but rather more difficult
Easier to do pIII now
Nah
Just go with the flow and proceed with pIII
Leave the FDA alone and do what they require as it stands now
What really happened in May?
There is a new CTD Blog....in the News section.
FDA rewrote the BTD rules and endpoint protocols in May.
Like I have been saying....FDA changed the rules on the BTD process right when PV-10 was up for the final decision. There is the evidence. It would seem that the FDA just took away BTD's surrogate endpoint protocol in defiance of Congress.......and there you have it people....time to stop pointing fingers and scratching heads.
In my opinion the FDA technically just killed off the BTD program....they gutted it.
Star Wars
First there was " a new hope"
Followed by " the empire strikes back"
We are in this episode right now
Next comes " the return of the Jedi "
Coming this summer
We get to see the death of the emperor and vader
Exciting
The rebel fleet has gathered
We attack the Death Star
Not yet
Waiting for freed up money
To my understanding the auditors require a line of credit to insure things continue.
They use to have a $30mm line of credit backed by shelf shares with Lincoln park capital
It was never used
Likewise this will be the same and will replace the old line of credit
Shelf shares and not dilution as a last resort
It is only dilution if they use the credit line
I understand this line of credit is required to prevent a letter of going concern.
It is not something to be feared even at this moment
I have been through all of this with Miller Energy stock.
Hit piece, heavy shorting and baseless lawsuits.
Their stock dropped like a brick and recovered.
Lawsuits eventually went away.
I am not concerned one bit.
Everyone is pissed at the low pps.....I understand.
Everyone wants to blame somebody....common reaction.
It is still my firm belief that the FDA was guiding them all along but at the final decision some at the FDA thought it unwise to approve without the PIB data because that sets a precedent of approval with waiver on PIB. I don't like that but I can see their point. Every Tom, Dick and Harry pharma would now be asking for the same waivers. Prior pharma BTD's would be pissed they had to go through all the steps.
I have been following the company for five or six years. I remember each and every time mgt met with the FDA trying to lock in a PIII trial design. I remember that the FDA kept changing what they were asking for and the problems of PVCT being asked to put a square peg through a round hole. Recist protocols and the statistical analysis that goes with it has an inherit problem. How do you measure progression in a lesion that ablates in a day? How do you measure pain when none exists? The equations cannot take a zero input. How do you do a true double arm-double blind study? There is no approved intralesional therapy as a true comparator....the drug is not a systemic drug when you are looking at ablation....there is no red injectible drug so the blind part of the study is meaningless. Everything about running a PIII with pv-10 is a compromise on protocols. And way back then the FDA would not move.
So for all of you who wish to complain that mgt is inept at running trials have no clue what you are talking about.
Moving forward...the PIII will be run...albeit a compromise on comparator protocols....something I expect they will workout with the FDA now that they have more interaction with them now. I am waiting to hear more details.
Money? There are enough warrants out there not converted yet to put two or three more quarters of cash in the bank. There is still the fabled China/India licensing deals in play which I now think it's finally at the end. I know its been over a year of this talk but I think the company is close to getting a MOU. If that happens then more than enough money should come in as upfront fees to run a few PIII studies in my opinion. If they close....and I say "IF"...then they will run their own studies in their own countries which will go faster than the one here. And "IF" that happens then you are going to see big income from sales.
Another forward thinking statement......historically small pharmas get gobbled up when the mid point study data is out. The company has enough money right now to get to that point.
These are my opinions based upon my DD. Everyone else do their own.
I plan on increasing my position as disposable income allows.
Why? Because now the PIII study will be able to treat all lesions as many times as it takes to make the tumor go away....and what do you think that data will look like?
I will know more in a week
I am hoping.
Some people have limits to the perceived bad news. A tactic used by the opposition with great effectiveness. I have not sold.
Are there foreign license deals in play?.....yes
Upfront license fees, hurdle payments and percentage of sales....typically.
First money comes in when a deal is signed.....hopefully enough to run a PIII without touching money in the bank and have money left over for operations. Years in the making?....yup. Are we there yet?...I think so....but nothing is certain....I am watching closely the progress.
Yes
But now they have showed their hand.
Time to adjust and move forward.
We have all been given a map of the minefield.
The drug works
I plan to start increasing my position
Wouldn't it be neat if a new FDA program comes out of the right to try laws
The ability of stage IV patients to try whatever they want and the drug makers have to keep the statistics and provide a rolling ongoing study.
No I haven't been in contact.
They have enough on their plate without me bugging them at this moment.
I am looking forward to see if they can close a foreign license deal finally.
Such a deal would put money in the coffers to silence the critics of lack of money for pIII should they need to do that. It would silence the dilution critics as well so I think this is very important they get this done.
They got plenty of money for a bridging study and we will get to find out their plans during the conference call.
Now looking at the trading graph....... Damn it's flat!
What does that mean? From my point of view it means the scarred weak hands are mostly out.... Good.
It also means it's been highly controlled..... No volatility.
Now observing level 2 it looks like it's been kept in that range while big blocks of buying are snuck in here and there.....I think someone wants to accumulate at a low pps..... But you should watch your level 2 along with time and sales to validate my observations. If more institutions buy then the less the effect of bs hit pieces and bottom feeding law firms. Such veracity of the hit pieces and bashers at this pps leads me to believe something else is on their agenda besides shorting. I have an idea but I will wait till I have more evidence.
Asco
Then conference call
Thoughts
After thinking and thinking and thinking
Even if the drug cured 100% of the time and also cured ED and caused the patient to crap gold bricks
Even the FDA probably decided that an approval on that type of study without PIB data would set a precedent and give them all kinds of grief down the road from other drug btd applications
I think the FDA probably thought in the type c meeting that skipping that data was no biggie
But more conservative heads were thinking down the road at the final meeting about the fallout
Just that
A rumor based on nothing
I got nothing on my radar
Most companies have insurance for this crap
That's what the bottom feeders are after
I have got news that a big bank/institutional bought a large chunk yesterday....more of this stops the volatility.