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He disposed of 25,000 options
His shares went up by 25,000
Nobody in mgt sold shares
It's on the record.
If we get an MOU on China by end of June then I see it going up. That will take the cash worries out of the equation.
And yes, I know that's been bantered about for over a year but the second guy on the SAB is a China/India deal expert and PVCT got that China bank on board....time to close now.
The FDA probably decided not to set a precedent by allowing a BTD for that indication without having the pain, bleeding, infection data even though the company was probably told they could bypass that. I say "probably" but I am pretty sure that is what happened in my opinion.
Now that the FDA has decided not to waive any detail the company can proceed forward with that detail by doing a study....simple.
Aggravating yes....but straightforward now.
Lawsuits.....more just a form of free advertising for the Law Companies and The Street. I saw nothing in there to be concerned about. They based it all upon innuendos by AF.....Yawn.....a tale told by an idiot, full of sound and fury, signifying nothing.
A cookie to the first who guesses who said that.
Timing of denial letter.....IT guys can show the email times and when it was clicked on if that was how it was sent. Registered mail shows the date and time it was signed for the hard copy. Hotel and travel times easy to track....no worries there. And even if they did hold it a day...SEC rules you may hold on to material news for four days.
Stock price....the volatility is over for now. The stocks started trading partial penny trades late afternoon indicating that the retail sellers are out. The weak hands are gone and institutional holdings are likely up.....in the long term that is better news for those still holding. I am expecting slow accumulation by hedge funds and institutions. If anybody declares a 5% stake then expect a buyout offer though poison pills are likely in place to prevent hostile takeover.
Moving forward....we have ASCO, conference call and hopefully regional deals coming up. If such a regional deal closes with large upfront money and the stock is still low then maybe we get a stock buyback to reverse much of the dilution and still have money to run the company and a full PIII if they have to go that route....though I do not expect a PIII but a bridging study instead. Denial of the BTD for now should not have an impact on foreign licensing deals since they were waiting on what a trial design or what the path should look like. That design is clear now.....so bring on the MOU's soon please.
Multi hedge fund takeover attempt.
This is what it is all about.
I may be wrong but the buying blew past the short covering and is going in big blocks to big to be retail.
I cannot predict what the share price will do
Nobody can
How long is a short study? When the last enrolled patient completes it.
To the others who don't care for what I post
I'm sorry to come off sounding the way I do
I've just been around this probably too long
I work very hard at finding things out through conversations and my own research
Please take it as just another form of info for you to use
But please do your own dd
I'm not trying to sugar coat the reality that things look sucky right now
But I think they can pull it back from the rabbit hole by doing a study that has all the data
Most biotechs get kicked in the nads by the FDA on btd's
They correct and resubmit
If they were told they needed to do it they would have done a trial before btd
I suspect (based on many things) they were given a waiver on that part by the btd advisory committee
But at the final decision others in the FDA likely thought that would set a new precedent of approving the btd without that data and overruled. In hindsight I can see why they did.
So the sent a letter saying try again but with that data
And I think they will when they do a short study to include it.
I am hoping for the end of June but that is my opinion.
China will also be doing liver studies as well.
Australia was waiting to follow the FDA.
China and India just wanted to know how to design their short study and now they should have an idea.
Let me guess and say we may know by end of June.
What you have is your notes. You don't want to play that card and shoot yourself in the foot.
What do you do?
You do your best to design a short study based on the letter to include pain, bleeding and infection.
Again....what was told to them by the FDA in December does not show up in May.
Common sense...if the FDA says to do something....that is what you do. They did exactly what they were told to do regardless how that letter makes them look.
To do otherwise is naive and wasteful and the dumbest fool would not make that mistake. They are not fools.
The answers I am about to give is the truth as I know it from being in conversations with mgt over the past five years.
I remember each and everyone of those FDA meetings about PIII trial designs. I remember when PVCT would have their meetings and comeback with word the FDA wanted something changed. I remember back then mgt saying that the FDA had a problem with this new type of drug and that the regular PIII trial design the FDA uses doesn't fit. I remember mgt saying it was a moving target to get them to nail down a design. I remember when they finally got some agreement made on the SPA/PIII (over two thousand page application) only to have them say the FDA said hold off and go the BTD route....It's new and shiny and fits your drug better. That December meeting I thought was the BTD meeting.....in a way it was. They went in with the MM indication just like what was in the PIII/SPA design. The FDA told them no....go for local regional control...an unmet indication. Go get the data in the subset group and see if it can pass on that. Now about that pain data......that was not required. If it was, then PVCT would have come out of that meeting and said short study to get pain and bleeding data. But during the BTD decision some at the FDA did not allow, obviously, the waiver the initial FDA group gave on that pain data.
Could they prove this? Yes and no.
The FDA does not allow recording of the meetings. You may only take notes. PVCT does have their notes but if they are released publically and the FDA gets embarrassed then you can kiss your application goodbye for the next five years.
Those that think the mgt is inept don't know the real story.
They did exactly what the FDA told them to do.
In a very strange way I think the refusal benefits everything in the long run. They are now required to do another study which I hope requires them to treat every lesion as many times as they like.....with results like Moffitt's. So Moffitt's data at ASCO will be something to look at. If it matches Moffitt's data then there is proof needed for our buyout money we wanted. I don't think it will be a PIII because the letter acknowledges that all that was wrong was the missing data for symptom endpoint....pain, bleeding, infection....for that type of BTD. They have to prove it's better than standard care, so for symptom based endpoints you are going to need all symptom data. Some communication with the FDA in the next week might shed more light.
This is just my opinion.
Two different FDA committees involved on both ends
At the start the group that advised them to btd
On the end the final review committee
Now let's say you or I was told to btd and what to go for
Common sense says that's what we do
Otherwise it's a waste of time
I'm proposing they did what the first group said
Let's assume that for arguments sake
Now at the very end the FDA says no
How could this be if the data was good?
It's btd
Another middle finger to congress for imposing it on them?
Influence by big Pharma?
Or was the final committee loaded with the old guard?
Who knows?
I'm just throwing that out there as just another plausible explanation
Now what's being bantered around is they did something contrary to the advice of the FDA
That's suicidal
They are not that dumb
Who created BTD?
Congress did.
Why?
To get needed drugs approved without all the red tape.
Did the FDA want the BTD law?
No. It forces them to approve things quicker.
Has the BTD process been effective?
Not really....they deny more drugs than approve. Many resent the congressional intrusion on their turf.
It's in a pr somewhere awhile back.
I'm sure they are still pursuing that asap
Pretty sure that was what china and India was all about
Plenty of money to be made there
I don't know yet....I need to get more info. But I will say this....I think the proverbial bridging study will ensue followed by another BTD app. I bet this time they do not disclose that app like most companies do not....hard lesson. The mess will eventually clear up.....retail holders not in long positions will probably leave for good and institutions and hedges will step in for the fire sale. That is my opinion. It's going to take a few weeks to see where this is all going. In the mean time I am still hoping for a China and India deal. They were always posed to do their own study and whatever the new study is they will copy in my opinion.
This is a setback but not the end.
If a short study is done I am hoping for all tumors treated as many times as it takes to get them to go away. And that should do it.
I will not advise you to buy, sell, or hold.
I will say I am holding.
In a few weeks when the stock does what is does I will post a pic of my portfolio here to prove it. I have always been for the end game
The drug works even if the FDA does not.
I say sell the company to China...piss on these shannagans.
Who are you addressing that too?
I'm not laughing......I don't like the delay...I don't like the idea shorts wanted to raid at $3...that was too low for a raid....I don't like the sure footed taunting by them. If this thing is not approved then someone had insider info and will be trying to steal the company.....this smacks of hedge fund dirty dealings.
Come on news....
If this was true....and I have no freaking idea...it would start the bidding war. I hate not knowing....goes against my nature.
I am waiting like the rest on whatever this is.
Should be today if FDA on time
Btw.... Who nuked my Henry the V post?
It's funny!
Basing the investigation that they should have done a PIII instead of a BTD....LMAO!
The nature of the up front money depends on the BTD. Lets wait and see.
Submit my Imcor post.
I don't do SA
Imcor came out of the split when MGT founded PVCT. Back then certain shareholders wanted to stick with the diagnostic technologies while PVCT mgt wanted to go the oncology route. MGT came away with PV-10 and founded PVCT and Imcor got the diagnostic technologies. PVCT still here and Imcor went belly up. Imcor was photogen.
Short attacks are easy......the twitter feeds start ramping up. As far as the Fox interview I was told that in a conversation which I relay here if I hear new things. If you have been following me for two years you would know this.
Canceled by Fox
Fox Business Interview Cancelled
Seems like the interviewer's husband good friends with AF
It would be nice if they get word from the FDA by then. No one can predict the exact time of the email....could be Friday....could be next Tuesday.
I am very optimistic.
In hindsight one could see this raid coming. Its possibly the last day to banter around innuendos on no news. People are wound up tight waiting for the BTD decision. Emotions are high and that's what shorters rely on.
This house is made of brick.
The wolves can huff and puff all they want
The two expiring patents are for photogen outdated patents. What you may not know is that there is a PV-11 and PV-12 which work a bit better and is covered in the synthesis patent which when pv-10 has expired will provide protection for decades to come. You need to be very good at organic chemistry to spot them. That synthesis patent was awarded last year. You have zero worries.
My Response to the Disclosed Short and his Article
By Jkrywyn_John posted on Investor Village
If you notice he is short. He also uses not facts but tries to use circumstantial evidence and he tries to use insinuations. Not accusations.
1. Four employees: There is no argument there. To insinuate that a company with four employees means anything negative is ridiculous. MULTIPLE cancer centers are doing clinical studies. The FDA designated PV-10 orphan drug status and they are under compassionate use CUP program. They work at the Oak Ridge National Lab.
2. PVCT is not “connected” to paid stock promoters. This guy uses anecdotal evidence of other companies and tries in a a roundabout way to connect them to Provectus. Not true. No facts to support this.
3 PVCT has worked with an SPA for Phase 3 with the FDA and were ready to proceed. Then the FDA radically changed their structuring. Essentially, the FDA reshuffled their organization and management was working with CDER for SPA (who had no experience with local agents and SPA for melanoma, according to the blog). Management and consultants thought they would get SPA summer 2011.
The CCDER and CBER staff were "reshuffled into DOP1 and DOP2 (division of oncology products)
Essentially, the people they dealt with changed. Then, as they likely got back on track (they suggested it set them back a year), in early 2013 BTD became an option.
BTD would get the drug to market faster so they are pursuing that and have had a cooperative working relationship with the FDA
4. To suggest they had PH-10 and PV-10 in their last company - also a lie. They were a laser company.
5. Compensation is in line with other pharmaceuticals. Also - nothing there but anecdote and insinuations.
6. PVCT is a biotech startup. Average companies brining a cancer drug to market take over $1 billion dollars and ten years. They have been working quicker and have used well under $200 million. They have been working with several hospitals - the leaden in cancer research including Anderson and Moffitt. Most startups, unfortunately, don’t get favorable financing. They had to use Network 1 and no longer do.
7. PVCT has not made claims. They have shown data and clinical researcher and the most renown doctors and cancer hospitals have shown data. This guy says nothing about data but linking to Adam F who has also never refuted the data. He has also claimed he bashes PVCT for “Sport"
Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt's excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the No. 1 cancer hospital in Florida and has been listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer since 1999. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion
http://www.pvct.com/news/PV-10-EADO-2014-May.pdf
look at the data
8. The recent changes were being pointed out by SALLY CHURCH and myself @jkrywyn on twitter contacted management. There has been no decision and you do not and cannot know that until the FDA announces. I think you’re mentally challenged. make it true. They made the changes to the website and Adam F went ahead and wrote the article he was insinuating he would right saying it was false advertising. He wrote it anyway making (again - a baseless one) an insinuation that this meant something or another.
9. It’s impossible to be worth $0 when your company has $18 million in cash. The company has a blockbuster drug and those who were not scared out or shaken out stand to profit when more progress is made.
Lastly:
In 2006 his father’s account purchased and profited $14,000. Dr. Argawala paid a fine and he has recently disclaimed not to own any Provectus shares. He had made a mistake before this company was even an idea in his mind. Again. A reaching insinuation. No fact.
http://www.sec.gov/litigation/litreleases/lr19568.htm
For drugs the patent is 20 years plus a possible additional 5.
It is uncertainty which can be taken advantage of in a bear raid.
Institutions
Patents expire 2031...not 2016.
The article is not signed.....it's an anonymous hit piece designed to tank the stock. Amazing that Seeking Alpha has stooped that low to allow it. Nobody is tied to paid promoters. But idiot shareholders can and do panic.....this is why institutional ownership is needed.
It's a lie.