I am very bullish on PVCT but this is an OTC stock and biotech is experiencing forced selling during a major market sell off. I fail to see why this drop cannot be blamed on the market. I like OTC stocks but they trade crazy because they do not have instutional buyers to stabilize them. You are at the mercy of the emotions of the mob. If you can't stand the volatility, you need to stick to listed stocks. I am buying and will continue to do so if PVCT breaks $2.00. If you look back over the past 3 months, PVCT has traded wildly during that period, but it has made it up from $1.30. Diodia
What the bears do not grasp is the difference that toxicity makes. If your drug is toxic and causes, say, deaths from pneumonitis, the FDA is going to want to see survival benefit to compensate for the pain and misery the drug causes patients. It is because PV-10 causes almost no side effects that the FDA would be willing to approve it without a primary or secondary endpoint. All PV-10 has to do is give the patients a significant net benefit, i. e. relieve symptoms. Diodia
I am not an expert, but my research indicates that India, China, and even Australia will wait for the FDA. I agree about the test sites. Diodia
I think there is a good chance BTD will be denied on the basis that a short bridging study is needed. If this happens my best guess is that there will be a steep drop in price which will last only hours and perhaps much less, as everyone but the traders realizes that BTD will be forthcoming before long. So you can wait to buy half if you agree with this idea and if you watch the stock like a hawk, as your plan would then make sense. Diodia
The low PVCT volume seems to me to bode well. In a biotech sell off, hardly anyone is selling PVCT. Almost no one is buying because longs bought in anticipation of the BTD application announcement and also on the dip to $2. Longs are already loaded up. I think we will be in a trading range between $2.10 and $2.75 until the FDA responds to the BTD request, and that if we spike outside of that range, it will not last long--until the FDA news breaks. Diodia
The incredibly low volume seems to me a good sign. We are in the middle of a sizable market sell off, and hardly anyone is selling. It makes sense to me that almost no one is buying because longs bought in anticipation of the BTD application announcement and also on the dip to $2. Longs are already loaded up. PVCT is not immune to the pressure of a market sell off, but the low volume is positive. Diodia
I should have made it clear that I think the odds of PVCT not being eventually approved are extremely low. It seems to me quite possible that the FDA will not grant BTD without an additional study, and possible that they will not grant it at all most probably for political reasons. But I think PVCT would still be worth at least $2 even without BTD. A Phase 3 survey for a symptom reduction drug will be much shorter and cheaper than for a drug with adverse events trying to prove that the benefits outweigh the downside. Diodia
It seems to me probable that PVCT will move in a trading range between $2.10 and $2.75 over the next two months. If there is a big market selloff (and I don't see why there shouldn't be, as this is the right time of year and there is Ukraine and also China), it could go lower. If there is interim PVCT news, and there probably will be, the share price could go higher. But I think it will not spend long below or above the range, and should spend most of its time between $2.10 and $2.75.
Just a few weeks ago our trading range was c. $1.50 to $2.00, and last year there was a long stretch around $1. So now the market recognizes a new and higher range of valuation, around $600 million.
We expect a response to the BTD request to shift PVCT to a new range based on the news. but even if BTD is denied, I do not think it will stay below $2 for long.
Obviously the shorts on this board think otherwise, but I think the odds of PVCT failing to clear the very minimal palliative, symptom-reduction bar discussed with the FDA are almost nil. The expansion of the MD Anderson compassionate use program pretty much cements the status of PV-10 as a "useful drug." Clearly, longs are hoping for much more! Diodia
If I were a short and did not know anything about PVCT except what I read from Adam F, and I saw that the market was going down hard and that the biotech index was down 7% or whatever it is, and I saw PVCT spike on what does not really seem to be news, just mailing an application,, I would short the hell out of PVCT just on general SOP, especially since that has been a winning strategy in the past every time PVCT has spiked. PVCT is a small cap OTC stock and there is nothing Dees or anyone else can do to stop this, but I think PVCT will come back up fairly soon, although it may have to go to $2.20 first. Diodia
I bought at $2.56, $2.43, and 2.33. I am hopeful that $2.32 is the low, but the market is cratering and biotech in particular is collapsing, so who knows. I think the Waxman hearings may actually help PVCT and I think the company may say things or make changes to the fact sheet or presentation that goose the stock. But it is a wild bucking bronco OTC small cap, so who can say. Diodia
There are so many ways to make money that people should follow the different paths they feel comfortable with. There is no one way. If you have been trading this stock since October, you have made money. If you have been long and simply held since October, you have made money. If you have shorted PVCT every time it spiked you have made money, as long as you paid no attention to Adam F and waited for the spike. People should follow their different paths, and not scorn others who take a different path. This is not about being a morally superior stockholder; the goal is to make money, however you do it. If it works, it works. DIodia
I am trying. Heaven knows PVCT is volatile. So far so good but I was a nervous wreck when they made the announcement Friday as I had sold all of mine. I have bought half of it back, and I am bullish long term. Diodia
I bought half of the PVCT that I had sold last week back a little over what I sold it for. Whew! That was scary. I was so convinced that there would be no news Friday afternoon and that the market would go down today on China. I think PVCT may go down more, but I am hoping for $3 before too long. Diodia
I am the most cowardly short that ever lived, but MRK is selling off hard and there has to be some reason. I cannot find any news, so if anyone follows this one, I would love to know what is going on. Diodia
Does it have anything to do with problems with their cancer drug? It started going down last week and I shorted it just based on the chart. Could it have anything to do with PVCT ? Diodia
I don't disagree about efficacy. The question is what constitutes efficacy. As I read the press release, the FDA is saying that they want more than tumor ablation to qualify for the large clinical benefit that justifies BTD. PVCT seems to have argued, what about those other drugs you approved just on tumor ablation, what about the clinical need for radiation which does nothing but shrink tumors. The FDA harping on prospective tracking of symptoms, higher dosage, and injecting all lesions makes me think a bridging study is very likely, but maybe PVCT can satisfy them with the data from the 28 patients. Diodia
I don't do any fancy charting with candlesticks, etc. When PVCT got past 2.13 I posed it would go to $2.30 and when it got past $2.30 I posted it would go to $2.60, just based on the little head and shoulders. I sold all of mine on the $2.80 run and bought it back at $2.13 and under $2.05. I am afraid I will miss the big price run, but I just cannot help myself. Diodia
I sold almost all of my PVCT between $2.50 and $2.60. I am bullish but I am a trader and I just cannot help myself. I had enough shares to make me nervous as I always am. Diodia
Yahoo cut off the last words "and India." I cannot give the URL but the title of the press release is Provectus's PV-10 Path to Initial Approval in U.S. Now Clear Per FDA Meeting Minutes
Friday January 24, 2014
I spent two hours on it, and basically I think PVCT is arguing that they already have the data needed to justify BTD and the FDA is focusing a lot on the symptom relief which may or may not be in the existing Phase 2 data. Diodia
PVCT's path to approval will shift its focus to symptom relief and to less advanced disease--Locally Advanced Cutaneous Melanoma. BTD requires preliminary clinical evidence of a large treatment effect, which we have: the rapid tumor destruction demonstrated in the melanoma Phase 2 trial. The FDA agreed with PVCT that ablating tumors provides the large clinical benefit needed for BTD --but with the proviso that the ablation must correlate to demonstrated effects on one or more symptoms (e.g., pain, infection or bleeding).
PVCT points out that reducing tumor burden is the justification for radiation and much cancer surgery--the most commonly used cancer therapies. They argue that tumor shrinkage / objective response criteria has been considered direct clinical benefit in other skin cancer drug approvals, and a similar case can be made for PV-10. So PVCT will base its BTD submission on the phase 2 data.
They may also need a small bridging study in which the FDA advises them to (1) inject all tumors, (2) use the higher dosages of the compassionate program, and (3) correlate symptom endpoints --such as pain, infection or bleeding--with tumor ablation as the study progresses. The FDA agreed to work with Provectus on quantifying symptom control.
[ What I read between the lines here is that PVCT will try to demonstrate the symptom relief from phase 2 data they already have. But the fact that the FDA is so specific about what it would like to see in a bridging study makes me think PVCT will have to do one with all tumors injected, the higher dosages, and the tracking of symptom relief. I do not see why it should not be quite brief, as PV-10 works so rapidly in ablating tumors. ]
PVCT said they had $18 million in cash reserves and would not need additional capital or a partner to conduct a bridging study. The study would also support the requirements for licensure in Australia, Europe, China