But there is a huge number of people with eczema & psoriasis, many of whom are in pain and suffering infections and who hate the disfigurement. As far as I can tell, many of them are not keen on taking corticosteroids. If PH-10 works, the FDA is wrong to be endlessly exacting about approving a topical medication that peoplel have had put in their eyes --their EYES, for pete's sake--for over half a century. Corticosteroids are not risk free!
But I guess this is logic rather than procedure. I really hope they approvet PH-10. My heart goes out especially to infants with dermatitis--a nightmare for them and for their mothers.
I did check out the website. Thanks very much.
A $5 billion dermatology market sounds like a juicy target and would yield plenty of revenue and a much higher stock price even at much lower levels of penetration than 25 percent. Diodia
I saw some vague references to the MOA trial in the PVCT blog, but they said nothing specific. As someone who is not knowledgeable about such matters, I do not see why PH-10 should not create a huge revenue stream just on its own.
I wish I knew more about PH-10. I understand that PVCT has successfully completed Phase 2 trials of PH-10 as a topical treatment for atopic dermatitis and psoriasis, and that some sort of university study is ongoing, also a MOA study. What is the timeline on these PH-10 studies, if known?
The SeekingAlpha article has PH-10 as almost 30 percent of PVCT's valuation. Without necessarily accepting his valuations per share, what do people here think of PH-10 potential in terms of revenue? He breaks down his estimated valuation as follows:
Cancer or........Tx 2013...CAGR...penetra...Market..NPV.........NPV
Disorder..........$ Mil........assume....3 yrs......entry...Discount....share
Melanoma....$ 2,341.......3.0 %....35%....2016.....25%....$ 6.33
NonSm Lung...5,954......3.0 %....25%....2017.....35%.....24.59
Small Lung........653.......7.0 %....25%....2017.....35%........2.84
Atopic Derm...1,892.......3.0 %....20%....2015.....25%.....12.37
Base Case Net Present Value of Gross Profit
(60% of Revenue) per share =...................................$ 110.64
For him, Non Small Cell Lung Cancer and Psoriasis would be the biggest revenue generators. The number given for total amount of money spent on breast cancer treatment is far larger, $10 billion as opposed to $5 B and $3 B, yet it is projected to contribute only about half as much in revenue.
The only thing I don't like is "In addition, our discussions with several potential international licensing partners are not affected in any way.” You would be more likely to say that if the FDA had said you have to wait. Then you would say that our talks with international partners are not affected. You would probably not say, the FDA just approved our Phase 3 trial but our talks with international licensing partners are not affected in any way. In fact you would probably figure that the FDA seal of approval would increase the confidence of your international licensing partners and that FDA approval would affect those talks.
In any case, this meeting may not be that important. Diodia
Thanks for the good information! Very helpful. I just cannot see the FDA not approving PV-10. How could it then turn around and approve some more toxic oncology drug? Since drugs that are destructive of cancers have some toxicity and since there will not be any drugs less toxic than Pv-10, FDA oncology approvals would have to come to a halt, or be blatantly discriminatory. They have no downside in approving this, and plenty of potential upside. So I believe that it has been PVCT holding back, not the FDA, and that we can now move forward. Diodia
One great thing about holding the patent jointly with Pfizer is that Pfizer has an army of lawyers to defend it. Any company seeking to retweak if would face an expensive challenge. The patent is US 8530675
I would love to hear some chemists who read this board weigh in on "iodinated xanthenes in high purity" and all the rest of it. But as of now I feel that if it is novel enough for the Patent Office and good enough for Pfizer, it is good enough for me. Diodia
"There are two formulations of RB (for liver function and ophthalmic testing) already approved by the FDA, so in theory any compounding pharmacy could buy RB off the shelf and formulate into an injectable product, they just can not call it PV-10."
That was of course my point. Do you see it as possible to evade the current patent held jointly with Pfizer by formulating RB in a different way? The article on the patent talks a lot about the level of impurities allowed for injectables and how they achieved it, but I do not have the knowledge of chemistry needed to evaluate whether this could be achieved in a different way. Diodia
Vorlon, thanks for the reply. I am new to this stock so I appreciate feedback. I did look at the article on the patent from the link in the SeekingAplha article, and it seems satisfactorily complex, but I am not a chemist. Of course it is held jointly by Pfizer and they should know what they are doing. If our view is correct, things should move swiftly for PVCT from this point forward. Diodia
It seems to me that the Achilles heel of PVCT was always the patent. Why prove that a substance which has been essentially an industrial chemical for 125 years can be effective against cancers and strive for FDA approval if once you have done that, every pharmaceutical company can get to work manufacturing and selling it? In order for FDA approval to do any good and in order for partners to be interested, PVCT had to be confident that they had a patent that could not be evaded by another company changing some of its molecules. After all, Rose Bengal itself is the ultimate in off-patent.
So they delayed going forward with the FDA and further clinical trials until they had a patent for PV-10 that they thought could not be easily circumvented. Until then, all their good clinical data was useless in terms of ever generating revenue even with FDA approval. Only when they had the patent did they push for FDA approval.
So once they had the process and the patent, then they moved forward. This is why it took seven years, not any problems with clinical efficacy, specificity, etc.
Anyone have thoughts about this, or whether the patent could be circumvented by some form of Rose Bengal tweaked differently? Diodia
Very interesting post. I think PCVT may be selling shares to raise money. Some one is, and the seller eases up every time PCVT goes below $1.58. This is how the huge volume of buyers is being absorbed.
My guess is that it adds to PCVT credibility, also PCVT'S data seem better to me. But many people are reacting to the ONCS data by buying PCVT. I would love to hear others' comments on why.
According to the Lampoc Record's Nov 29 article, there will be a series of meetings for public comment on California's Environmental Impact Report for statewide oil and gas well stimulation activities. I would be surprised if the environmental people did not show up and have a lot to say and there should be press coverage, at least locally. So it will be interesting to see how ROYT investors react to all this.
The meetings are
Oakland, 4 to 8 p.m., Dec. 10, Oakland Convention Center, 550 10th St.
Sacramento, 4 to 8 p.m. Dec. 11, Tsakopoulos Library Galleria, 828 I St.
Bakersfield, 4 to 8 p.m., Dec. 12, Kern County Library Beale Memorial Auditorium, 701 Truxtun Ave.
Ventura, 4 to 8 p.m., Jan. 8, Ventura College Performing Arts Center, 4700 Loma Vista Road.
Long Beach, 4 to 8 p.m., Jan. 9, Long Beach Convention Center, 300 E. Ocean Blvd.
ROYT investors who live nearby, feel free to attend and express your views!
No, it is not. m20m75ph has a much more sophisticated model that says it is not, but here are the numbers for my more simplistic approach, with figures for barrels per day and monthly production::
Dec 2011 3,458 Boe/d x 31 = 107,200 boe monthly production
Jun 2013 3,243 Boe/d x 30 = 97,300 boe monthly production
October 2013 (31 days)............109,170 boe monthly production (from the Distribution release)
If PCEC/ROYT were not allowed to steam inject Orcutt wells, production would decline, but I see no way that could happen. Ruellia
jonesville, Yes, ROYT was a trap today -- for shorts hoping for a massacre.
Any idea why? I have been buying all the way down, but it has been quite scary. I still think, as I have said several times, that the 96 wells will get permitted and that a healthy distribution will continue. The threat seemed to me to be about growth prospects and therefore how the stock was valued, as I said. But some good news has to be out there.
Anyone reading my posts (there appear to be some investors in ROYT this afternoon for a change!), be aware that I have made no statements about income, revenue, or distributions. All the numbers I have provided have been production and reserve numbers. It is easy for people to get confused about this. You have to extrapolate the income, revenue & distribution numbers yourself based on the Trust's treatment of Developed vs. Remaining Properties, and the fact that they do not break out production along those lines.
I continue to be very long ROYT, although wishing that I knew more.