Many, many thanks jack for your posts. It is thanks to you that I loaded up below $14.50 and again below $14. You made detailed arguments, both big picture and company specific. This will make a big difference for me. Diodia
You are correct that there is a lot of data showing that PV-10 is effective. The allegations made in the SeekingAlpha article were all false. The PVCT patents are not about to expire and the company never used stock pumping services or newsletters. It is all a pack of lies. Getting a BTD denial is not a big deal and happens all the time.
The real problem is Adam Feuerstein, Nate Michaud's chat room, and PumpStopper at SeekingAlpha, and they are a huge problem. They will be stomping all over the stock on Monday, and there will be another article on SeekingAlpha saying that PVCT s worthless and going to zero. The stock is going to get crushed.
I listened to the Conference Call and reviewed the data one more time, and I think if you have a very strong stomach and are willing to be quite patient, you can invest on Tuesday, probably around $1 or below. I feel that in the end it will be approved. But that may be after a Phase 3 trial and a secondary to pay for it! Diodia
Any hope resides in the bridging study, and the fact that they have the cash to do it.
What Wachter says are the positives from the denial letter:
FDA said that they saw indication of drug activity--the drug is doing something to the tumors
They said recurrent melanoma is life-threatening, and is an appropriate disease for BTD
PVCT may submit a new request
Wachter says the agency has helped PVCT define endpoints vastly different from PFS.
Also has given good guidance on endpoints and types of patients to enroll
Negatives (which I find somewhat scary):
pain turns out to be really difficult to measure
most melanoma patients in earlier stages of disease do not have significant pain
He does not have a good way to assess pain & does not want to rely on patient self-report
I thought that correlating pain, infection, bleeding with tumor shrinkage in melanoma patients would be easy. Now it looks harder than I thought.
I am also worried about Culpepper's optimism. I believe he bought stock and exuded good cheer and confidence because he really thought they would get BTD. But they did not have the data, and I think Wachter was worried all along, but no one listened to him.
The biggest negative is Adam Feuerstein who is not going to let up. Diodia
I really think that if they had disclosed the letter, this would not have been that big of a deal, and could have been partially fixed with an ASCO announcment of the parameters of a new bridging study and the good clinical data in the ASCO presentations. I could believe Wachter on not receiving the email just because it was so crazy not to disclose it, and it is not as if they waited to disclose it until they had some kind of plan or path forward, because they gave us no path forward or details of the trial today. But why not disclose it when they got the paper letter on May 21?
There are some positives, mainly the cash in the bank, ASCO is coming, and the fact that they now say they are committed to giving the FDA what it wants: correlation of OR with pain, bleeding, and infection. On the negative side, Wachter said many melanoma patients do not experience pain until very late stages, plus that pain is hard to measure. I do not know about infection and bleeding, but I wonder how common they are. Adam Feuerstein is out there and will be relentless. The stock should get crushed on Monday, as many have predicted.
What they did right was to publish the FDA letter and to hold the conference call. Wachter says they have good guidance from the FDA on endpoints and the types of patients they should enroll. Culpepper seemed confident--but who knows-- on their connections with oncologists being sufficient to recruit patients. Next week will not be fun. Diodia
I don't see fraud, but PVCT has opened itself up to accusations of untrustworthiness at the very time that AF and PumpStopper are making these accusations that they are "fraudsters" and fly by night. The BTD denial was perfectly survivable--lots of drug companies get denied BTD. Denying receipt of the letter is really going to cost them, and the shorts are going to hammer on this. Plus they will be sued about it. I cannot imagine what they thought they were doing. Diodia
The FDA told them what they wanted--a study with all tumors injected at the high dose, and tracking of clinical symptoms (pain, bleeding, infection). PVCT refused to listen. What worries me even more is that they did not disclose the FDA letter. I think they must have gotten the email on May 16 and they got the hard copy May 21, and they did the press release on May 21 saying that the FDA had not reported back to them.
I think this ensures that PVCT will be sued. All of this is going to create a ton of negative publicity. I can understand why they did not want to disclose the denial on the day of the listing, but they should have disclosed on the Monday. Everyone will wonder if management can be trusted, especially with PumpStopper and Adam F saying that they are crooks. Very depressing.
God knows what they will come up with for the Conference Call. I cannot think of anything that will help. They are going to be asked some awkward questions about the letter.
People on the board have been saying that the BTD request was a waste of time, and I now think they were right. It would have been better to wait for the release of the ASCO abstracts and the listing, and then announce a phase 3 after the ASCO presentations.
Agreed. The problem was not the subset of patients but the subset of tumors. I think the FDA was worried that the tumors injected might show bias, and not be representative of all the patient's tumors. The worst of it is that PVCT ignored FDA guidance. Diodia
What if they got BTD and Pfizer or a Chinese firm offered them a development partnership? Not a buyout, as I do not want to get too giddy, but a partnership? And they were going back and forth over the terms and who has to pay for the Phase 3 trials and all the rest? That would take quite a while. I do think the longer the halt lasts, the more likely that it is not just about the BTD and might be something positive. Diodia
Michael Dell started out selling hard drives out of his dorm room, where he stored them in the bathtub, and when he moved up to selling whole computers, Goldman Sachs lent him something like $18 million. There are many other examples, although I think Apple is the best one. You will make more money reading the trials and evaluating the science than to base your trading on random circumstances. Diodia.
and they bought more shares. Bayer allowed an employee to join the Advisory Board. I do not see how the news can be that bad. The longer the halt lasts, the more optimistic I become. But I cannot rule out BTD denial either. Diodia
No more convoluted obfuscation about concepts you do not understand? Just plain name calling? Now the "expert" mask is off and the low life basher is out in the open. Diodia
It claimed that the company had told a few select investors that BTD was denied, and then it opined that this was not fatal. I do not see why they would halt the stock 2 hrs for that, but what do I know. For now, I am not believing anything but the official news when it comes. Diodia
That could be a polite way of saying that there are a lot of naked shorts and it is going to be a problem if the stock moves up substantially, particularly if a hedge fund made a big bet. I appreciate your posting this; it is the one scrap of information we have. Diodia
Don't forget that the insurance companies line up on the other side of this. I have read several articles on managed care beginning to draw the line on fantastically expensive cancer drugs that make the patients life a hell, cost a fortune, and extend life for 3 months during which the patient suffers like a dog from side effects. There are constituencies which Roberti+White will be able to mobilize. I thought it was a good sign that Kyprolis has bombed in terms of revenue, as it is one of the toxic cancer drugs with poor results, bad side effects, and adds only a few months of life. We may lose this battle, but there are forces on the side of cheap and effective treatment, too. If the USA turns its back on PV-10, China may not and Costa Rica will add one more treatment to its array of offerings for American medical tourism. Diodia
Vorlon is out on the town, enjoying the bright lights and swinging doors, while you sit hunched over your computer, stewing in your own bilious resentments. Diodia
I agree completely, but PumpStopper and AF will be singing a different song about what it all means, e.g. doom for PVCT, and will lay out their certainty that this proves PV-10 is worthless and unapprovable due to subgroups, retrospectiveness, and "obsolescence" and suchlike goofiness. I expect many investors to be baffled by the BS given the deference that I have seen given to RE's nonsense. Evidently polysyllabic words hypnotize some people. I would really like PVCT to announce BTD tomorrow morning, but if it doesn't I am ready to buy. Diodia
eddie, I am on exactly the same page as you although I did not do as good a job as you did with the run up. I sold at $2.65 and $3.40, and bought back from $2.50 all the way down to $1.76, so I admire your trading. Some attacked me for selling, but I think we did the prudent thing.
If BTD were to be approved tomorrow, there would be a spike not only due to excitement but also to the short interest. It is impossible to borrow shares to short on Fidelity, so there would be an insane short squeeze. I originally thought PVCT would not get BTD without a bridging study, but then Clovis changed my mind, and tonight I do not know what I think. But I feel we can take advantage either way. Diodia
I believe that tomorrow we will get PumpStopper's part 2 from SeekingAlpha with his take on the clinical side of things. It will be centered on the bogus nonsense about "retrospective" and "subgroup analysis" that AF was tweeting days ago and which RE has been faithfully repeating on this board. This article will be backed up by an article by AF on theStreet "wondering" about all the "issues" and urging investors to avoid PVCT. So brace yourselves; tomorrow could be a day of fear. I bought more shares today under $2 but I am saving dry powder for low bids tomorrow if events unfold in a way that gives AF and his allies the opportunity to terrify investors. Diodia
bbinzel, you seem very rational, focused on the fundamentals and calm about the volatility to me. You have certainly never said that America disgusts you or any such, and I cannot imagine you doing so. How were you censored--was a post deleted? If so, I think it is outrageous, especially as b_g's scurrilous venom is allowed. Diodia