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Please show links backing up what you said
"HLNT aint gonna pay PWC a dime in cash."
those 2 links you provided don't prove it
please provide working links to back up your post
Thursday,Oct 11, 2012 STATUS CONFERENCE 54
10:00am
hope to see an update later today
http://iapps.courts.state.ny.us/iscroll/Appearances.jsp?IndexNo=600893-2010
thanks for the info
rand0m, appreciate the update on short numbers, where are you finding the daily short numbers? if you don't mind sharing, tia
Thanks Gatsby for the info and links
Simple question: How and Who is paying for all of this. I agree that they have done a really good job of communicating what is being done now and what the path forward is. I know they are doing it, but am curious as to where the money is coming from at this early stage.
you need to be an investor or shareholder.........baaaaaaahaaaaaaaaaaaaa
CEO sold 10,000 shares the other day, pursuant to Rule 10b5-1 Plan.
http://www.flotekind.com/investors/financial-reporting/sec-filings
Ran across this via twitter
link at bottom
Thursday, 4 October 2012 My thoughts on Sarepta
Although I do not have any positions in Sarepta Therapeutics (SRPT), yesterday I was consistently berated by the entire Twitterverse for suggesting that their phase 2 for Eteplirsen in Duchenne Muscular Dystrophy (DMD) study would not in fact be sufficient to pass the FDA’s sniff test for accelerated approval. Here I will spell out why:
1. Regulatory Precedent
The FDA has laid out guidance for any sponsor developing a therapy for rare diseases which is nicely summarized here. The presentation includes a nice description of the size of NDA submission programs for recently approved orphan therapies.
The good news is that orphan products are eligible for Fast-Track, Accelerated approval paths and Priority reviews, however, the same regulatory standards that apply to regular drugs still have to be met:
Regulatory Approval Standard
Orphan drugs are held to the same statutory requirements for demonstrating effectiveness and safety
Orphan drugs must: Demonstrate substantial evidence of effectiveness/clinical benefit (21CFR 314.50)
Substantial evidence of benefit requires: Adequate and well-controlled clinical study(ies) (§314.126)
“Study has been designed well enough so as to be able “to distinguish the effect of a drug from other influences, such as spontaneous change…, placebo effect, or biased observation” (§314.126)”
So, does the P2 study in question have “Substantial Evidence of Effectiveness”, is it “adequate and well-controlled”?
There is absolutely no rational argument that n=4 patients receiving therapy is adequate to establish conclusive efficacy. I have yet to see any baseline demographics on these study participants so who knows if it was well controlled between the two study arms, not to mention the selection bias for who was entered into this study to begin with. Only the initial 24 weeks were blinded to treatment so the risk of observer bias cannot be excluded for the 48 week data presented yesterday; the investigators knew all study participants were on treatment at that data point. Single center studies also introduce an element of bias which must be taken into consideration when reviewing these results. Bias aside, all participants had to be on steroids to be enrolled in the study. Steroids can effect ambulation performance; can anyone tell me what dosage of steroid these participants had throughout the course of the study and if there were any differences between the two groups?
According to the FDA Guidance:
What constitutes substantial evidence of effectiveness?
-Typically two adequate and well-controlled studies
Independent substantiation of experimental results – single clinical experiment not usually considered adequate scientific support for conclusion of effectiveness
Let’s just assume for one wildly optimistic second that that FDA was to consider Accelerated approval with a single study, what would be the regulatory requirements?
Accelerated Approval is based on surrogate endpoint where the surrogate is reasonably likely to predict clinical benefit
and usually requires post-marketing studies to verify and describe clinical benefit
OK, that doesn’t sound too bad. Afterall we have the muscle biopsy data. But wait a second, let’s take a closer look at that. According to the company data which can be found here:
Treatment Arm
Mean Change from Baseline in % Dystrophin-Positive Fibers
p-value
Eterplirsen (both doses): 48 wks of Tx (n=8)
47.0
=0.001
Eteplirsen 50 mg/kg (n=4)
41.7
=0.008
Eteplirsen 30 mg/kg (n=4)
52.1
=0.001
Placebo/Delayed Tx: 24 wks of Tx (n=4)
38.3
=0.009
Placebo/50 mg/kg Delayed-Tx (n=2)
42.9
ns
Placebo/30 mg/kg Delayed-Tx (n=2)
34.2
ns
The patients in the 30mg/kg arm actually generate more dystrophin positive fibers than the higher dose group, yet, this did not translate into a significant improvement on the 6-minute walking test.
Treatment Arm
Mean Change from Baseline in 6MWT (meters)
Estimated Treatment Effect (Eteplirsen minus Placebo/Delayed-Tx)
p-value
Placebo/Delayed-Tx (n=4)
-60.3
Eteplirsen 50 mg/kg (n=4)
+27.1
87.4 m
=0.001
Eteplirsen Both Doses (n=6)
+7.3
67.3 m
=0.001
Eteplirsen 30 mg/kg (n=2)
-31.5
28.8 m
ns
In other words, taken as is, this surrogate does not predict clinical benefit (as defined by distance on the 6MWT) at all. Can anyone explain this? I doubt it, I am certainly not convinced this is an accurate biomarker, nor is it particularly pleasant to be subjecting these participants to multiple muscle biopsies. (For the sake of brevity, I’m going to skip what I have learned about DMD trial end points and biomarkers from a brief review of the literature). Surely a blood based biomarker would be more practical? It seems that is what the company had in mind. According to the original study protocol here they were prospectively testing this as a secondary outcome.
Secondary Outcome Measures:
· Secondary efficacy endpoints will be the change from baseline in: CD3, CD4, and CD8 lymphocyte counts in muscle biopsy tissue
The presence of these lymphocytes is correlated with muscle damage in DMD, so you would hope treatment would show a depletion in counts with treatment. So what happened to these data, did they mysteriously disappear? I have feeling they were negative and the company just decided not to disclose them.
2. The regulatory bar set for other companies developing DMD therapies
Obviously Sarepta is not the only company in the race to develop a therapy for DMD. A quick search on clinicaltrials.gov reveals numerous open, industry-supported, phase 3 clinical programs in this condition -in other words, phase 3 programs are required despite the unmet medical need.
The most similar agent to Eteplirsen in development is GSK2402968. Of note, they have N=54 patients in their phase 2 study
and over N=180 in their phase 3 programs.
If you examine the P2 GSK protocol, you can see that they actually reduced variability in the results of their study by having subjects complete 2 separate 6MWT at baseline as part of the inclusion criteria.
“Able to complete 6 Minute Walk Distance (6MWD) test with minimal distance of at least 75 meters, with reproducible results (within 20% of each other) at Screening Visit 1, Screening Visit 2 and at the baseline visit prior to randomization”. This reduces the risk that any differences at important study visits were due to normal variability.
They also had tighter controls around changes to steroid doses that were allowed during the study.
Sarepta did not assess the reproducibility of their results at baseline at all.
What I find particularly interesting is the statistical powering of the GSK phase 3 program:
Primary Outcome Measure: To assess the efficacy of subcutaneous 6 mg/kg GSK2402968 versus placebo; specifically to have 90% power to detect a difference in 6MWD between GSK2402968 and placebo of 30 meters, assuming a common standard deviation of 55meters. In other words, 6MWT is so variable that a 55 meter difference between 2 individuals would not even be considered significant.
Clearly the clinical development folks at GSK have put a lot thought into their study protocol and have looked at baseline individual variability a bit harder than Sarepta. What would the Sarepta data look like if they were adjusted for such a measure of standard deviation?
To reiterate, I have no financial position in Sarepta. I advise everyone to take a closer look at the data and consider the prospect that this drug may not be all it has been hyped up to be. Based on these facts, the suggestion that it will be approved via an accelerated approval pathway based on the existing data is frankly ridiculous.
This article is not intended as trading advice. Conduct your own due dilligence prior to buying or selling securities.
Posted by Aafia Chaudhry, MD at 11:51
http://aafiachaudhry.blogspot.com/2012/10/my-thoughts-on-sarepta.html
trademark it.....that was a good one
starbuxsux, I did see the PR and liked what they had to say, but was asking about Rev. #'s for last couple of months, cash balances, etc. like they used to do. I guess they are not giving out these kind of numbers anymore in between earnings reports
Appreciate your feedback. I'm comfortable with the other number and the fact that someone made the $6mil offer
I thought they offered the $6mil for 1/3 of Company's authorized shares?
There are 5 Billion Authorized Common Shares last time I checked.
The following is a quote of the tweet yesterday.
"Today, EPGL has declined a $6mm offer by an Investment Banker to purchase 1/3 of Company's authorized shares.
12:12 PM - 3 Oct 12 · web
Reply
Retweet
Favorite
Options
1 RETWEET 1 REPLY"
18,000,000 ÷ 5,000,000,000 = 0.0036
Can anyone here verify if they heard on a CC or Presentation recently that FTK will no longer be giving any forward guidance?
Thanks in advance
A New Jersey hedge fund manager has admitted to running a $4 million fraud.
Michael Spak pleaded guilty to conspiracy to commit wire fraud yesterday in Camden, N.J., federal court. According to prosecutors and a lawsuit filed by New Jersey’s attorney general, Spak and his co-conspirators at Osiris Partners ripped off about 76 investors, lying to them about their performance while spending money on unusual investments, such as a $300,000 sport fishing boat. Osiris also allegedly inflated the amount of assets it managed to charge more in management fees.
Prosecutors said that Spak, who served as the hedge fund’s CEO, and Osiris marketed their wares to “little guys” and “mom and pops.”
Spak faces up to 20 years in prison when he is sentenced in January.
This is what should be happening to CR and sidekicks
HOUSTON, Sept. 26, 2012 /PRNewswire via COMTEX/ -- Flotek Industries, Inc.
("Flotek" or the "Company") today announced that it will host institutional
investors and securities analysts for a three-day tutorial on Flotek products
and services October 1-3, 2012 in Houston and Oklahoma City.
During the investor days Flotek will discuss a number of key initiatives for the
balance of 2012 and the coming year including advances in its patented Complex
Nano-Fluid, or CnF(TM), suite of oilfield chemistries, progress in applications
of its CnF products for Enhanced Oil Recovery and recent expansions of its
chemical research and production facilities.
The meetings will also provide tours of the Company's Woodlands chemistry
research facility and Cavo Drilling Motors facility in Houston and its Teledrift
and CESI chemical production facilities in the Oklahoma City area. In addition,
the Company will review financial and operational information and provide a
"hands-on" look at the Company's drilling tools product line.
Details are available by emailing Flotek's investor relations department at
IR@flotekind.com. Space is limited. The meetings will not be webcast but
presentation information will be available on the Company's website the day of
the event.
Golden Cross, Options expire today, news Monday, and vol. is picking up a little. Monday is going to be interesting
Thanks again for the on-going updates
Can't wait for Monday and the Short Roast
I'm Buying Today
Time for those 8,800,000 shorts to cover
Change in Directors or Principal Officers, Financial Statements and Exh
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Effective September 12, 2012, Mr. Jesse E. Neyman retired as Executive Vice President, Finance for Flotek Industries, Inc. (the "Company") and as an officer and director for each subsidiary of the Company. Also on September 12, 2012, the Company and Mr. Neyman entered into a Retirement Agreement (the "Agreement") that sets forth their mutual agreement as to the terms and conditions of Mr. Neyman's retirement and supersedes Mr. Neyman's existing employment agreement with the Company (subject to the continuing effectiveness of certain provisions as detailed below). Below is a description of the material terms of the Agreement. The description below is qualified in its entirety by reference to the Agreement, which is filed as Exhibit 10.1 to this Form 8-K and is incorporated herein by reference.
Pursuant to the Agreement, Mr. Neyman will remain an employee of the Company until November 30, 2013, performing such duties as requested by the Chief Executive Officer of the Company. Upon the effectiveness of a release entered into between Mr. Neyman and the Company within 21 days of the Agreement, Mr. Neyman will receive a cash payment in the amount of $220,000. During Mr. Neyman's continued employment with the Company, he will receive a monthly salary of $36,600 until November 30, 2013, (which employment may be terminated "for Cause"). Upon the effectiveness of a second release executed after November 30, 2013, Mr. Neyman will receive an additional cash payment in the amount of $110,000 and a cash payment in the amount of $200,000 on March 31, 2015.
The Company has agreed to continue health, dental and vision insurance coverage for Mr. Neyman and his eligible dependents until November 30, 2013, and to cover the expense of Mr. Neyman's COBRA coverage for the greater of 24 months thereafter or the maximum period provided for under COBRA. All unvested stock options and restricted stock awards made to Mr. Neyman shall continue to vest by their terms until November 30, 2013, with all such awards vesting on the earlier of November 30, 2013, or Mr. Neyman's death or disability (provided that certain of such awards whose vesting is conditioned on the achievement of target goals will remain so conditioned).
Mr. Neyman has agreed to cooperate with the Company and has acknowledged that the confidentiality, non-competition and non-interference provisions of his employment agreement remain in effect. Mr. Neyman has agreed to release the Company from all claims and liabilities he may have had against the Company as of the date of the Agreement and to enter into a subsequent release of claim and liabilities after November 30, 2013.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Description
10.1 Retirement Agreement dated September 12, 2012.
Upcoming IPAA conf. on 09/24/12 FTK speaks at 2:20pm
http://www.ipaa.org/meetings/pdf/122012ogissfpresentationschedule.pdf
What are the odds of getting guidance?
And How good is that guidance going to be?
NIR Group Investors Scream Valuation Fraud after Report of 97% Loss on Investments
Posted by Teri Buhl under Hedge Fund Fraud
No Comments
Investors in a troubled hedge fund founded by Corey Ribotsky were told by the funds’ liquidator last week their hopes of recovering any real money was slim. I reported on the 97 percent drop in valuation for Growth Capitalist today in a story that details how main street investors who gave their pension money to NIR Group’s AJW Funds are shaking their heads in utter disgust. Investor frustration stems from the notion that the SEC has gathered a ton of new evidence to support their claims of asset valuation fraud in a new amended complaint against the hedge fund manager yet the Eastern District of New York DOJ hasn’t charged Ribotsky with any criminal wrong doing yet.
Ribotsky even came to investors with his dick in his hand this March trying to claim he’d been burned by the market and lost millions also via the fees he says he invested back into the fund. This effort is spelled out in a seven page letter sent to NIR Group investors that you can read below. Keep in mind Ribotsky wrote this letter after a court appointed liquidator kicked him out as fund manager in January and then the liquidator showed investors a cash flow report that reflected a completely different picture than Ribotsky had told them for years.
There is a ton of new details in the story on NIR at Growth Capitalist so go ahead and register for free to read it.
Editors Note: Growth Capitalist is a new trade publication founded by one of my former Dealflow Media editors, Brett Goetschius, who has a ton of experience reporting on finance for the institutional and main street investors. If you’re looking for news that helps you with the kind of investment research that hedge funds pay big banks millions of fees for Growth Capitalist could be a good starting point.
http://www.teribuhl.com/
NIR Group Investors Scream Valuation Fraud after Report of 97% Loss on Investments
Posted by Teri Buhl under Hedge Fund Fraud
No Comments
Investors in a troubled hedge fund founded by Corey Ribotsky were told by the funds’ liquidator last week their hopes of recovering any real money was slim. I reported on the 97 percent drop in valuation for Growth Capitalist today in a story that details how main street investors who gave their pension money to NIR Group’s AJW Funds are shaking their heads in utter disgust. Investor frustration stems from the notion that the SEC has gathered a ton of new evidence to support their claims of asset valuation fraud in a new amended complaint against the hedge fund manager yet the Eastern District of New York DOJ hasn’t charged Ribotsky with any criminal wrong doing yet.
Ribotsky even came to investors with his dick in his hand this March trying to claim he’d been burned by the market and lost millions also via the fees he says he invested back into the fund. This effort is spelled out in a seven page letter sent to NIR Group investors that you can read below. Keep in mind Ribotsky wrote this letter after a court appointed liquidator kicked him out as fund manager in January and then the liquidator showed investors a cash flow report that reflected a completely different picture than Ribotsky had told them for years.
There is a ton of new details in the story on NIR at Growth Capitalist so go ahead and register for free to read it.
Editors Note: Growth Capitalist is a new trade publication founded by one of my former Dealflow Media editors, Brett Goetschius, who has a ton of experience reporting on finance for the institutional and main street investors. If you’re looking for news that helps you with the kind of investment research that hedge funds pay big banks millions of fees for Growth Capitalist could be a good starting point.
http://www.teribuhl.com/
$7.00 trade, that's rich, hope it cost them more on fees
I expect an announcement on 09/21/12 for the IPAA conf. in San Francisco. http://www.ipaa.org/meetings/index.php?mid=152
where I expect July and August numbers on Revenue and Cash on hand to be announced. I think Flotek is speaking on 09/26/12, but don't remember where I saw that info.
Nice trade, the new short numbers were in yesterday, around 8.4 million shares still short as of 08/31/12
Now that makes sense, I knew there was something besides the "Stuff" being said, like just looking out for NIR Fund investors.
Report predicts decade-long surge in U.S. oil production
Posted on September 10, 2012 at 12:09 pm by Jennifer A. Dlouhy in Oil, Shale.
A Mountain Ridge Drilling rig of Daugherty Petroleum -- which works 24 hours a day, seven days a week -- is pictured 26 October 2005 in the Appalachian Mountains of eastern Kentucky. Most of the 900 or so wells drilled in Kentucky this year won't produce more than a barrel or two of oil a day, but with prices topping USD 60 a barrel, those little wells are pulling in big profits, especially when they also pump natural gas. AFP PHOTO/JEFF HAYNES (Photo: JEFF HAYNES/AFP/Getty Images)
U.S. oil production is forecast to grow by 74 percent over the next 10 years, fed by a boom in harvesting crude from dense rock formations across the country, according to a new analysis released today.
The report by Platts’ energy data unit Bentek Energy, says the increased domestic production will dovetail with a decline in waterborne imports from 6.7 million barrels per day in 2011 to less than 1 million barrels per day in 2022.
“We foresee a massive displacement of traditional waterborne oil imports to the United States by 2022, taking them from 45 percent of U.S. total crude supply to no more than 5 percent,” said Jodi Quinnell, Bentek oil analysis manager in a release summarizing the report.
Other analysts, such as those at Citigroup, have been similarly bullish in recent months. Almost all tie the projected spikes in crude projection to development from shale and other so-called “tight” plays.
According to Bentek, the decade-long increase in domestic crude supply will also send oil prices down in North America compared to other parts of the world.
http://fuelfix.com/blog/2012/09/10/report-predicts-decade-long-surge-in-u-s-oil-production/
Thanks again for the new charts Do you know off hand if, or how many ETF's FTK is a holding in? TIA
I am NoBody, and that previous message by Valiant was a great post
pdgood, for a person with not even one penny worth of skin in the game, and no right what so ever to the terms of the settlement that have not been released to the public, what's your real interest? I'm pretty sure, you have never saved one person invested here even a dime. What's your real angle?
If the terms of the settlement are "public", why are you asking a NIR Fund investor for them? And please state cleary the Benefit that investor stands to receive.
The part I still don't understand is why or how YOU having that information benefits NIR Fund investors. Especially since you don't have any skin in the game.
Let me repeat the question. What benefit will NIR Fund investors receive by passing on the information You requested to You?
PD, please explain to NIR investors exactly how you having that info. is going to help NIR investors? (since you are neither a shareholder of HLNT or NIR Funds)