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Lame, Lame, Lame - Shame, Shame, Shame
It was really lame of the company not to post top-line results, but just results from the sub-group that showed favorable results. This is a really sleazy, shameful way to do things.
Nano;
You hit the nail on the head! IPIX management keeps issuing glowing press releases about their drugs, but still doesn't have a licensing deal for any of them. According to IPIX, many NDA's have been signed, which means many companies have had a chance to take a detailed look at the trial results, but no license agreements have been signed. What do all of these companies know that IPIX isn't telling us?
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Be careful with PEIX.
October 2014 futures are $1.50/gallon lower than April 2014.
CME ethanol futures
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I had to laugh...
when I read the following phrase in the PR.
“Additionally, I am pleased to inform shareholders that we plan to soon announce a new novel drug specifically designed for the treatment of leukemias as we make the next progression in growing our cancer drug franchise,” concluded Mr. Ehrlich.
This little company is talking like a big pharma. With the caliber of their people, and the caliber of the drugs in their pipeline, they might even get there.
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New leukemia drug
From the PR
“Additionally, I am pleased to inform shareholders that we plan to soon announce a new novel drug specifically designed for the treatment of leukemias as we make the next progression in growing our cancer drug franchise,” concluded Mr. Ehrlich.
I guess now that they've added a 3rd employee (Dr. Sylvia Holden), they decided they'd need to put a 3rd drug into clinical trials to keep the team busy.
LOL
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MD Anderson mentioned in IDEAS conference.
At 28:55 into the IDEAS conference, when Dr Menon was talking about their cash situation, he mentioned that most of the institutions they were working with were paying for the trials themselves, or were giving Cellceutix preferential treatment, rather than asking Cellceutix to pay the full cost of the trials. One of the examples he gave was MD Anderson, which I believe is the first time MD Anderson's name was specifically mentioned as a collaborating institution (although a number of posters on this board have speculated that they were negotiating a collaboration agreement with CTIX).
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A short update on TATF.
As of ~ April 10, 2013, TATF's websites are no longer online. TATF has only intermittently replied to e-mails or phone calls for several years, and then only to provide vague assurances that more information would be forthcoming soon (it never was).
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I suspect that there won't be many PR's about the phase I Kevetrin trial until after ASCO - I'm sure they don't want to steal Dr Shapiro's thunder. Also, conferences expect that previously unpublished material will be presented.
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Any idea on what's holding up the loan from Shinhan bank?
IIRC, back in 2011 their cash flow was insufficient to support the dividend, and they were essentially paying the dividend out of their cash reserves. Their cash reserves are now almost depleted, so they will either have to:
1) Cut the dividend
2) Borrow money or issue more shares to support the dividend
None of these options are likely to be helpful to the share price.
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Actually, despite its name, GORO derives most of its revenue from silver.
The recent drop in silver and gold prices will have a material negative impact on this one. Unless silver and gold prices recover quickly, GORO will have to cut its dividend in the near term (perhaps to zero).
Also, the lack of a feasibility study, which requires substantial drilling to prove up reserves, means there's low visibility into what production will be both in the near and long term. Still think there's more downside than upside on this one.
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Of course, if the divvy is cut, the SP will drop, so better to wait until after the cut b4 buying this one.
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Attractive, but unsustainable. Expect a divvy cut within the next 60 days.
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Nice job Karin!
What's nice about this latest study is not just the result in retinoblastoma, but the empirically observed correlation (in other drugs) between efficacy against multiple cancer lines in animal studies, and efficacy in humans. In other words, other drugs that have been effective against multiple cancer lines in mice have had a much higher success rate in clinical studies than have drugs that have been effective against only a few cancer lines. As the positive pre-clinical studies for K continue to climb, so does my confidence that the clinical studies will be successful as well.
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The one approach to offsetting human CO2 emissions that might actually work:
http://en.wikipedia.org/wiki/Iron_fertilization
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OMEX An unconventional mining play worth a look.
Maybe it's the next NUS.TO (hope not, LOL).
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Celgene's PH III trials for psoriasis drug show modest efficacy.
Fierce Biotech Story
The line from the story that I found most interesting was:
Recall that the majority of dermatologists do NOT use biologics--thus, even though apremilast's efficacy is below biologics, we believe its good safety profile and the ease of oral administration could drive significant use.
The opportunity for Prurisol continues to look exciting.
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I don't consider my comment re the Prurisol schedule to be negative - just realistic.
Actually it's now looking more like late second quarter, not late first quarter.
Prurisol schedule.
Looks like the Prurisol POC trial in Europe will be later than originally expected. From the company PR on February 25th:
Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013.
My understanding is that, as part of the formulation stage, Dr. Reddy's must verify that the drug is stable for a 60 day period, ie, once they've produced a batch using the final manufacturing process, they must test it, store it for 60 days, and re-test it, to verify it has remained stable over that time.
If they finish the first batch using the final manufacturing process by the end of March, the schedule might look like:
Initial test: 1 week (finish on April 7th)
Store for 60 days: 60 days (End on June 1st)
Final test: 1 week (finish on June 8th)
This implies that the POC would start around the end of June, assuming all goes well.
Assuming all patients in the trial begin the trial by July 15th, and the trial takes 60 days (30 days of dosing, followed by a follow-up 30 days after the end of dosing), puts the end of the trial at Sept. 15th. Assuming 15 days to analyze the data and put out a press release puts the date for a PR on the Prurisol POC trial around Oct. 1 - significantly later than I'd been expecting.
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IMUC vs NWBO
Seems a little simplistic to me to talk about IMUC only being in ph 2 and NWBO being in ph 3. IMUC has 278 patients enrolled in their ph 2 study, whereas NWBO will have a total of 300 in their phase 3 study. If NWBO will truly not finish enrolling until Q4 2014, they will likely not have top line results until the end of 2015 - a full 2 years after IMUC has top line results. Given the number of patients in IMUC's ph 2 study, IMO it's likely that their drug will be approved if their phase 2 results are similar to their phase 1 results, simply because the phase 1 results showed such a huge improvement over the current std of care (ie, there's a pressing unmet need in the treatment of GBM, so the first drug with impressive ph 2 or ph 3 results will likely be fast tracked for approval).
A1
I'm new here too, but the fact that they waited until May 17 2012 to change the estimated primary completion date from June 2012 to June 2013 speaks for itself.
I looked through the history of changes for this study. It showed that, up through April 5, 2012, the estimated primary completion date was June 2012. Then, on May 17, 2012, the estimated primary completion date was changed to June 2013. So, I wouldn't put a lot of faith in the estimated primary completion dates posted at ClinicalTrials.gov
NWBO trial archive
Yes, still recruiting patients.
Again, from slide 12 of the presentation
"Primary endpoint: PFS (progression free survival)
Endpoint will be satisfied by 6-month extension of PFS"
So they will need more than six months once all patients are enrolled, so June 2013 is an impossibility (and, come to think of it, June 2014 may be difficult as well).
Yes, the trial started in December 2006. Clearly the timeframe for topline results cannot be 16-18 months from the start of the trial. Seems reasonable to me to assume that they mean 16-18 months from the time of the presentation.
We're looking at the same slide
16-18 months from January 2013 is ~ June 2014.
Also, a Seeking Alpha poster has come to the same conclusion.
NWBO Seeking Alpha article
See slide 12 of the linked presentation
NWBO Jan 2013 presentation
Karin;
According to NWBO's latest presentation (January 2013), top line results for their phase III GBM trial will be available in 16-18 months, ie June 2014, not June 2013.
A1
Also, in the pre-clinical trials, Kevetrin was tested by itself. Given that Kevetrin's MOA is different from that of all currently approved cancer drugs, it's highly likely that, in phase 2 trials, Kevetrin will be administered in conjunction with currently approved cancer meds, thereby increasing the likelihood of positive results even further.
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The quote I published talked about extrapolating from observed effectiveness in pre-clinical (ie, mouse) models to phase 2 clinical results. If you go to CTIX's website and read through their presentations, you will observe that Kevetrin was shown to be active in 100% of the mouse models they tried. The quote indicated a ~ 50% likelihood of positive phase 2 results if a cancer drug showed positive activity in at least 33% of mouse cancer models. So, since Kevetrin showed significant activity (ie, effectiveness) in 100% of the mouse models, my conclusion is that the likelihood of Kevetrin being successful in phase 2 trials is substantially greater than 50%.
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Kevetrin showed positive activity in 100% of the murine human xenograft tumor models tested. I think you may be recalling that 50% of human cancers are believed to contain mutant P53 genes.
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A quote from 'Tumor Models in Cancer Research (2nd edition)' edited by Beverly Teicher:
from page 7:
"...one can conclude that agents irrespective of their level of in vitro activity which have activity in less than 33% of [mouse] models tested had no "positive" phase 2 clinical trials. In contrasts, agents with activity in at least 33% of such models had an approximately 50% likelihood of positivity in phase 2 clinical trials."
Hmm, I wonder what the likelihood of positive phase 2 results is in an agent with activity in 100% of the mouse models tested.
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Tumor Models in Cancer Research
After 180 days (the duration of the study), the mice were 'sacrificed', so we'll never know how long (if ever) it would have taken for psoriasis to return.
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According to the study, there was no recurrence after 180 days.
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The Kevetrin/sunitinib combination was used in a murine human xenograft model. In other words, they implanted and grew human cancers in mice with modified immune systems (so the mice wouldn't reject the human cells). The cell line refers to the specific type of human cancer cells used in the study.
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Many of the articles which have Menon as a co-author list B A Teicher as the first author. I did some searching and discovered that Beverly A Teicher is now VP, Oncology Research at Genzyme.
She's also the editor of five books, two of which I've linked below.
B A Teicher book 1
B A Teicher book 2
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Yes, 20 years from the filing date, subject to adjustment due to delays at the patent office. The filing date listed on the issued patent is May 14, 2010, and the adjustment is 121 days.
So, the expiration date will be approximately Sept. 15, 2030.
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Drano;
I found that you are correct - apparently TD Ameritrade and IB will allow IRA's to be margin accounts, but will not allow leverage in these accounts, so there's little incentive to convert them to margin accounts.
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IRA Margin Account
Since IRA's are required to be cash accounts, shares held in an IRA cannot be borrowed for shorting.