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They will
95% Pv-10
5% other
Keep toxicity low
Appears combo works
Win win
Combination therapy
Notice all the pharmas cozying up to each other to combine two or three drugs in a combo therapy?
It will take that to get their orr high enough to look like they are effective
At a cost of up to $250,000 a treatment!
Dumb but desperate.
Gene therapy is having the cancer adapt and coming back meaner
Single antigen therapy is trying to choose the right antigens instead of the immune system picking them
They are all in trouble and some are very toxic
PV-10 is going to change the industry and they know it
Game of Thrones
I want to chime in here. Looking at level two I see plenty of large bids but at a nickle below the current price. On the sell side there are no shares offered really. So this looks like the sellers are really not interested in selling at this price and the buyers want a better deal....Mexican standoff.
The stock price is not evidence...it is a reflection of emotion and convictions and personal beliefs. It is also a reflection of group behavior. That's why TA works so well.
Biotech is complicated science and very hard to understand. Investors rely on the words of experts. Some loud false experts are listened too because they have a broad reach and a loud voice. A howling wolf scares the herd.
The science will win out over the howling of wolves in the end.
Another thing I might add for your questions....and I am just speculating...but the FDA already knew all the data and what was where. Under the new label a different set of formatted data has to go with the application. I believe that when the FDA broadened the label, they also knew where they would get that data...over there...out of those 28 patient sub set. Now the way I think....and I am a puzzle guy by nature...that may mean the BTD is the least of what they can get...if ALL the data found suffices then it should be OA. One step down from that is saying we think its very safe and we will release it but run that short study at the same time...AA.
Without cheerleading....this is just how I think. If the FDA said "NO!" it would all be over at the last meeting. They did not so reading and rereading all the 8k's and pr's I try to put the puzzle together...Like asking "what is the FDA doing and what did they want when they changed it?"
Never just stare at the evidence and say "oh well"
Everything has a reason.
Lets look at the past pr....it said they may need to do a short bridging study. That's a short study to bridge the data they have with the data they may need if what they have is not enough.
Now lets look at the still possible outcomes....make up your own odds.
OA...The drug is released....go straight to the NDA.
AA...The drug is released....But you still have to do that bridging study while you are selling the drug.
BTD...You have to do the bridging study before it gets released.
Any of those three are slaps on the back and a "well done boys".
Now what does a BTD mean if all the data is there and no bridging study is required...I think that means OA...I may be overstepping here and others should correct me if I am seeing this wrong.
I can only speculate since I nor anyone else can speak for the masses. That being said....
I think everyone is still smarting from the bear raid butt whipping. Some big players lost a bunch and are a bit too butt sore to jump back in. Others that might have jumped in saw the AF crocodile and are continuing to watch from the bank. Yet others think the market is too volatile. Of course, the biggest players cannot jump in until they get on Nasdaq.
If you are gun shy as you indicate then just multiply that feeling across the multitude.
In time that will change. Confidence will be restored and things will improve. We will await news that the company is moving the ball forward.
Everyone was expecting AA or BTD at the last meeting. Nobody saw what the FDA was going to do...ie...broaden the label so more can be treated. I did not see that coming nor did the ones I know. It is really hard come Christmas and expecting a bicycle under the tree only to be told wait a bit more for a motorcycle. Your feelings get hurt on a temporary letdown but come later when your on the Harley you will forget that moment.
The FDA did not say no...they said go for the bigger prize. The FDA said that...that was their guidance. So I have no worries at all about the outcome.
Lost confidence will be restored. They are PR'ing the BTD application to show the pressure will be on them to perform...they have no worries they can live up to it.
Your first point is 100% correct.
Who gets BTD and who does not.....
Those who do not get a BTD send in an application that was not guided by the FDA.....nor those who cannot make the drug in large quantities....nor those whose data is so close to background noise statistically that it is questionable if it even works.
Those that get approved do not do any of the above.
No...I think I said they would....somebody else said they would not. I asked if they would and they said they would PR it. I asked when and I was told I would know when I read about it....lol.
No volume...that will change.
BTD application PR will change that.
Some think mid March....much sooner IMO.
Company is not sitting on their hands...they have been very busy.
The 60 day clock will then start.
Same drug minus impurities
Instead of 95% pure
It's 99.9% pure
No problem with FDA on that
123TOM
At first I thought all your math was voodoo science.
Now I do not.....hats off to you for calling them!
Just something interesting to read.
http://www.slideshare.net/garg14ashish/10-important-drugs-discovered-by-accident
I have that info over on Yahoo....to busy right now to pull it over here
Both I think
They do not get paid that much.
Not now.
One time they did.
Approved by the board and shareholders
but not now.
At one point they had job offers for even bigger money elsewhere....I seem to remember someone saying...but I have no proof right now....just my memory.
BUT FOR CERTAIN....they do not get paid that right now
Pumped? Not exactly. I and others on yahoo have been posting the facts continuously to combat false statements and help put a floor on sp. If you call putting out the facts pumping then so be it. I am long. I do no recommending of buying or selling. I do try to answer questions and put out my observations. But compared to this board which is calmer.....there is war waging over on yahoo.
Actually they do read it....he has an ip address trap and can see.
And because you do not see big pharma right in front of you does not mean they are not moving. That is not the news big pharma wants you to know ahead of time to jump the stock up....IMO.
Most of his target audience is not us but big pharma and big institutions since their eyeballs are on his site now.
Oh I will win in the end...nothing wrong with the drug. Yes...I will hold on to my bag.
Because you can steal....must you?
Sarcasm likely
If everybody tried to sell out at $6 it would have dived quicker.....common sense. I am not a fan of short traders....there is a certain amount ick that comes from stealing another's wealth that quick. You, Nate and AF and your minions ganged up and raided the cookie jar. You guys did it with such art it almost begs admiration. In time the stock will rebound and there is nothing wrong with the company despite what your political science major (and not medically trained) mentor says. You guys know zero about science except for the science of stealing.
Watch the video
Look at this:
http://www.huffingtonpost.com/2009/03/11/jim-cramer-shorting-stock_n_173824.html
https://twitter.com/InvestorsLive
Bragging that he shorted the stock using the techniques
Quiet...yes...somewhat....just plain tired.
I'm still holding...nothing wrong with the company whatsoever.....just the siege of the castle from the raiding party. In time they will rally it up quick again....maybe even to $8 and try this again.
Until such time that stronger hands own this....they will be able to get away with it.
No Insider Trading
Brokers require a 144 form filed with SEC if any insider trades....and this has not happened.
Was this a pump and dump? Yes in a way.....my belief is that the bear raid people drove it up quick and then sprung their trap.
That was all them.
I still have not bought or sold any shares in over a year.
Today may be an end of month rebalancing in to another sector (an idea sent to me)...but who knows....
Btd is usually requested after pII
Per FDA website
For when your going to do something quicker than a pIII
Or why have btd at all?
Get a btd and the FDA tells you where the door is pdq
Right under my nose, I missed it!!!!!!!
Under my nose!
I am an idiot!
Right under my nose and I missed it!
The FDA wants a broader label!!!!
They said it's needed
They changed what they were wanting them to go for in the meeting!
It's now local recurrent melanoma!
A broader label!
The clock got reset!
So they are mining the data for the new label!
Not much!
Right under our noses!
Very good news in my opinion!
Anybody else see it?
Btd came in the picture and changed it all
Factor that in
Not at all
Up until the time of the initial btd submission back in sept
pIII with spa was the agreed route if my memory serves me
The patents were done
It is my understanding, though I have no proof, that the FDA thought pvct would be a good candidate for btd
Let me digress that in past conversations I have had that it is pvct modus operandi not to waste time or money on any trial without the FDA's guidance and permission. I base all my assumptions in other posts on this. They are very adamant on this. So if you see them doing something, saying something, not saying something, not doing something then you bet your dollar the FDA is aware and may be guiding them to do so.... My opinion!
That being said it is my understanding that the FDA said start the btd process
That made pIII obsolete because pIII was already agreed to
They just had to wait on the patent to go forward
Why then the FDA said go on btd and not earlier?.... Damn if I know the mind of government
But the drug you use going out the door has to be the one you use past pII
Now logic would say it better be damn near identical to the ones used in pI and pII
The current one uses 99.9% pure rb vs a less pure rb
The new formulation is pure enough to be accepted internationally for oncology
More protection for end game buyer
I will try to explain as best as I understand.
It can take some time to get the FDA to agree to a trial design...PIII
No...wait....FDA changes....SPA.....
No...wait....we are now thinking this......
Moving target delays on final trial design
Also watching progression on patients in pII
then.....omg they just figured out how to synthesize a purer form of RB that meets international requirements for oncology...very valuable for end game valuation..everything on hold
Apply for patents....wait on patents because PIII has to use the drug your going to use in the market.
Patents come.....everything back on track.....the FDA says why not apply for BTD now?
Here we are.
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
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.
It does sound misleading....I can see that. Why is the PR cryptic and hard to understand? It is not because of anything bad. The FDA said it was needed. There is a very good reason that will be very good.....thats all I can say.....believe it or not. I am sure I will be bashed because of this...so be it.
Its BTD
FDA said turn in the paperwork on BTD....60 days after we give you your certificate....we may make you do a short bridging study...something simple and CHEAP.
They said basically.....tie your shoes before you go out the door and play.....have fun.
They have tons of cash in the bank.
No more fund raising ever.
Are you kidding me? He's a front guy for the real culprits.....they raid and say it must be traders reacting to Foolstein.
Cheap to produce but sell what the market can bare
Big pharma going to wait 20 plus years?
If you are going to add more....perfect point.