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Things will move now faster than before
PIII is imminent
PIII enrollment begins within 30 days after filing
PII/III liver will follow in the weeks ahead
PI combo after that
SITC next week with new data from Moffitt
Zurich a week after that
I think Zurich will be important because it gives a chance for big Pharma to have follow up questions regarding combo therapy
India mou might happen in November
The China deal waits on liver protocols (no you don't need them to do a ho-hum deal but you do for the best deal)
China coming back to talk to Moffitt.....Moffitt runs a liver trial site
November ended up being a congested month for stuff...not a bad thing....bang bang bang
Keep eye on the Blog
He's watching government sites for us I'm told
Any new news would pop up on those sites and he's ready to report asap
A watched pot never boils
I am getting contacted daily by investors trying to find out whats going on with things. Indeed the PR out of PVCT is scant. So, as far as I can gather they are still working on the protocols....there are three sets....melanoma, liver, and combo. PIII on melanoma will start when protocols are deposited with the FDA, a China and India deal is waiting on the liver protocols I think. How much longer? I cannot ascertain that. I do know that each protocol will likely contain several thousand pages with more detail built in than you can imagine. These protocols, once finished, get sent out to several doctors and groups to be audited. Any changes adds a few weeks. The good thing is that when this is all done then the trials can begin that will be run by CRO's and compared to this, it will seem all down hill. Do I think these licensing deals will happen....yes.......plenty of upfront money?.....yes. A pain in the ass watching the pot until it boils?....yes.
Now back to the combo protocol rumor. If true then we will be seeing a combination trial with an immunotherapy to address the stage four patients that the PIII trial will miss. While a China and India deal shows the market that PVCT mgt can produce and a rise in sp surely follows, I am way more interested in combo work.
Over a year ago, I posted on yahoo that PV-10 will end up saving the immunotherapy market. I was laughed at by some....no matter, I have thick skin. Well it looks like I was right. Someone got Moffitt to do a combo mouse study.....those results to be published at SITC (http://www.sitcancer.org/) in early November. There is the human combo study rumor floating around and that PVCT is working on those protocols. There are indications that major pharmas are waiting with baited breath for that Moffitt data. Rumors, indications and heresays.....to be honest, that is all it is until we see evidence. If PVCT announces combo protocols then we will know all the speculation is likely true. So what does that mean? Big pharama looking for PIII data for the end game?....maybe. They did their own mouse studies with rose bengal and know it to work. Are they more interested in the combo data? I think so.
So to wrap this up. A China and India and other regional deals are important to shore up the bank account, demonstrate that others believe in the drug, demonstrate to the street that mgt can execute and to finally provide the capital necessary to purchase a roll of duct tape to silence all our bitching.
BUT.....the bigger stuff comes from the combo arena. Big pharma, like lemmings, all went diving over the cliff of immunotherapy. Now at best, they get to divide up, amongst ten or so drugs, the very small stage four market. They will be seeking that one drug to combo with them.
One drug to rule them all
One drug to find them
One drug bring them all
and in the market bind them
The Blog goes into more detail on this subject:
October 23, 2014
More of Better > More or Less of Worse
http://provectuspharmaceuticalsinc.blogspot.com/
They would be tight lipped about any deals until an 8k by law.
Was it not just a few weeks ago we had million plus share trading days?
Vanguard buys 3 million shares. Who's next?
I bet after SITC there will be a lot more buying.
As far as I know it is still just a contingency.
My point in my posts on the other site is that, in my book, China and India have become less important. That is not saying anything at all about licensing deals in the works. What I am saying is that SITC is bigger than I had thought. That the Moffitt combo data will be of upmost interest to big pharma.
I think the China and India deals will go through....that I am not worried about.
Once China and India were very important for increasing the stockpile of money to be used for trials. This may longer be the case. In November, Moffitt reports on their combo study with immunotherapies. All of big pharma, like lemmings, went down the very expensive path of anti-ctla4's, anti pd-1's and anti pdl-1's. What did they ALL find out? That the treatments are costly....$150,000 to $250,000 and that the ORR is very low so they went and combo'd with each other to raise it up...to some success...but not enough. They need a primer....there are only two....T-Vec and PV-10. T-Vec is toxic and PV-10 is not and works better. Inaddition they will all be sharing a small stage four market.
So.........Moffitt does a combo study with immunotherapies per possible request by big pharmas before initiating human combo trials. This has its roots in the fact that PV-10 successfully treated many Moffitt human patients that failed ALL available immunotherapies.
Which means....look for human combo trials with PV-10 funded by big pharma.
So what does that have to do with money for PVCT?
Eli Lily, Roche, Merck, Bristol Myers have got PVCT targeted and dialed in. Ely Lily and BMS both have tested PV-10 on mice themselves and know it to work.
My opinion.....with a raising....China and India become just a bonus. I think what I am seeing is that they are moving past that.
If there is a raising then it is a required raising by NYSE no matter if there is enough money to go to 2016. PIII is ready to start and no China and India yet. NYSE and BDO may require the money in the bank to take PIII to the end before PIII starts. A bird in the hand vs. two in the bush so to speak.
If there is enough upfront money from China and India then look for a share buyback to reverse the dilution if dilution happens. Both China and India has to close before that can happen. If these deals have tons more money built into the hurdle payments then even more share buyback likely will happen once hurdles are met.
Some of mgt will be going to the Chinese melanoma conference this weekend. Cross your fingers and hope they can conclude a deal there. Other region MOU's will or are in the works.
If the protocols are not back from the auditors in time for this weekend then they may extend the MOU by a month or much of the upfront money might be hurdled until they are done.
Such hurdled upfront money just waits until melanoma and liver protocols are filed.
I have posted on this topic several times. Please go back and read. Also there is a lengthly conversation on Investor Village you can go back on.
This weekend some of mgt going to the China conference. Cross your fingers.
I would think that coming over here to visit everyone involved would be a positive sign.
Bad idea to use cantor right now even if they are less.
The reason to go to the nyse was two things.
To allow more market access to the stock and to control volatility.
Cantor is the mm who buffers the sp
They buy into any sell off and sell into any rapid rise on no news
They prevent monkey business such as bear raids
Now if you use their credit facility then by law they go out of the box and can no longer prevent attacks.
If there is a raise then it may be NYSE requirement to have in the bank enough money to take the PIII past the midpoint and all the way to the end.
or.....
A raise or threat of a raise is known as leverage on deals. There are more regional deals in play than you are aware of.
The bank loans money to people who do not need it. Such might be the case here. The best way to win is to not rely on a win.
Never fight a battle that you don't already know you will win.
-Sun Tzu
Connecting my dots
The press release today by ERT got me thinking,
It is my belief this is an indicator the protocols are done and filed.
PIII can begin....starting with St.Luke
China and India can proceed.
Beijing conference is on the 18th.
Which means China should be visiting very soon.
And if they make that effort then a deal is likely been agreed to.
If a deal is agreed to or when they get here it most likely means that liver protocol is done and liver trials start soon as well.
India mou should be coming as well.
A China deal moves India to a deal which moves other regions to deals.
Then we got SITC in D.C. November 6th where Moffitt announces results from combo study.....which should lead to combo studies in humans.
Ladies and gentlemen.... I think we are back in the ballgame.
Evidence that PIII is starting:
https://www.ert.com/latest-news/ert-s-scientific-and-regulatory-consultants-support-phase-iii-oncology-trial/
Credit goes to Dooper55 on Investor Hub for finding this.
It was never said they were here. It was suggested they were coming. When you see a pr on protocols being done then I think you will have an idea on the timing of things.
Check your mailbox
My guess:
It is past the date to reset the delisting clock....we are now safe. So why do we see it held by the market maker very, very tightly? There can be only one answer.....welcome to the friends and family plan. Pending events, should they occur will help raise the sp.....Wall Street knows this. Until that happens....uncles, cousins, friends and family....step up and buy while we hold it right here....nice and slow.
it's either that or someone on Wall Street wants to make sure Tom123's batting average stays 100%
If you wish to meet someone, then a better choice would be Dr. Craig Dees. Call him up.
DCA decreases tumor by just a tiny percentage at very high doses. These mouse tumor models are hyper sensitive to metabolic inhibitors like DCA. It does open up ideas for other paths. No evidence of practical value yet but it should get them more grant money to study further.
This was not a PVCT related sell off. Check your news....everybody jumped out of everything. This was a tech related sell off industry wide. PVCT held up pretty damn good.
To make the point simpler. Replace CR with cured. When I say cured, I mean the tumor went away and did not come back. I am not saying the patient was cured unless they say patient had CR.
What does Christopher Kaplan bring to the SAB? A big rolodex....the ability to speed dial all the heads of all the big pharmas. He brings deep inside marketing experience. When he speaks to big pharma about PVCT...people will listen. He has experience in running a big pharma.....let that sink in. This was a very cool addition. He will be the defacto spokesman for PVCT to the industry.
OMG this is huge!
Re: Merck buys Sigma-Aldrich for $17 billion cash
False alarm....different Merck. This one is more like Sigma Aldrich drug maker than the BIG Merck
Merck buys Sigma-Aldrich for $17 billion cash
http://money.cnn.com/2014/09/22/investing/europe-u-s-takeovers/index.html?iid=HP_River
Because Dominic's program picked up the drafts
They were then taken down
Expect a press release in due coarse.
Read my latest on yahoo
LOL....the PR is not out yet. Dominic must have some type of software that grabs anything related to PVCT. Well it grabbed that before it was ready to be published. He said so on his blog. So we got a quick peek at what will be press released later in the week.
New Moffitt Study
In November Moffitt will be reporting the results of Immunotherpy combo study with PV-10 in mice.
Hats off to Dominic for finding that before an actual press release.
http://provectuspharmaceuticalsinc.blogspot.com/p/news.html
While on the NYSE the specialists are keeping the stock nice and cozy and safe. This is fine while there is uncertainty. But if China signs and PIII starts then worries are in the past until at least mid trial when the data gets peaked at. But we that want $40 plus per share need to see this much higher before end game.
NASDAQ has no specialists. It can rise higher and faster or drop likewise. I would like to see a jump to NASDAQ if China signs, good upfront money in the bank, PIII started.
Can we have everybody give a yea or nay? Kinda of like the Scotland vote.
90 days from the pr announcing it.
BTW....none of the events are FDA dependent.
While anything is possible....I believe it is highly improbable it will ever happen again. Between now and the end of the year there are a half a dozen news events or more that should be coming.
Protocols filed
China deal
Liver data
Enrollment
India mou or deal
Moffitt presentations
Combo study deal with big pharma
PH-10 MOA Study
If these happen, then that could lead to more regional mou's and deals and more.
I would like to see $75mm in the bank by the end of the year....wishful thinking but I am hoping.
Not unless your a market maker maybe.
Looks like someone took a one million share position.
It's the year Star Trek first aired
Lol