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The lawsuit is not for "health related claims".
Oops! .
Actually that as the point I was trying to make...
Only 6 per day? Unless you weigh less than 120 pounds, you are probably not taking enough. Perhaps that was the reason your wife did not see a benefit? I take twelve per day and was told at the Annual Meeting that I should be taking 15 to 16 per day. Here are some things I have learned from personal experience.
1) Anatabloc is dose dependent. If you do not take enough, it either will not work or it will take a LOT longer to tell the difference.
2) You have to keep it in your system. If someone is going to take it three times today, forget about it tomorrow, and then start back the next day; they should not be surprised if it does not work for them.
3) Keeping it in your system means taking it at least three times per day; not once or twice, but at least three times per day every day.
Also, your wife's Hashimoto's is probably "under control" using her current meds such that she is not experiencing many symptoms. The problem is that her thyroid is still deteriorating. She most likely would only see the difference in her blood work. Keep in mind that the thyroid trial overseen by Dr. Ladenson was a three month trial. Apparently the blood markers improved for all the participants; some back to normal and some were still improving at the end of the three month trial.
I don't think it's the same "Nancy Lopez" that you think it is...
I did a brief search and this is the only side effect I could find for ICPT's OCA product.
* Pruritus, a very common symptom in PBC patients, was the notable adverse event with a reported incidence in more than half of all the patients (placebo: 50%, 10 mg: 47%, 25 mg: 85%, 50 mg: 80%); severe pruritus and associated discontinuation rate (placebo: 0%, 10 mg: 8%, 25 mg: 8%, 50 mg: 24%) was dose related and appeared soon after initiation of dosing in susceptible patients.
I have been reading up on ICPT's OCA treatment for NASH. It is a daily treatment and the first patient was apparently enrolled in March of 2011. This was ICPT's PR which started the share price explosion... "Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that the FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period." O'Brien-Fleming statistical stopping guidelines for efficacy will be applied. This interim efficacy analysis will occur when approximately 50% (140 of the 280 patients) have completed both baseline and 72 week biopsies. Primary Outcome Measures: •Hepatic histological improvement in nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
So what do they mean by "interim analysis"?
From CinicalTrials.gov...
So it took 33 months to get 50% of the 280 patients through the 72 week trial. And what was the "primary endpoint"?
Again from ClinicalTrials.gov...
Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:
a.No worsening in fibrosis; and
b.A decrease in NAFLD Activity Score (NAS) of at least 2 points
ICPT's OCA treatment is apparently a far cry from reversing (curing?) the fibrosis which we feel will be the case with GALT's GR-MD-02. So if GALT's GR-MD-02 reverses fibrosis in a matter of weeks, why would anybody take an OCA pill for the rest of their life?
And don't forget that there are indications that GR-MD-02 may treat fibrosis in other organs. I think that I will hold on to my shares in GALT and keep my fingers crossed. If GALT achieves the same market cap as ICPT closed with today, our shares will be worth $410 each. But if ICPT is really worth an $8.5 billion market cap, then GALT should be worth more, a lot more...
Of course that is JMHO. GLTA
http://clinicaltrials.gov/ct2/show/NCT01265498?term=obeticholic+acid&rank=1
I remember reading up on ICPT's product as a potential competitor for GALT. I do not remember the specifics, but I came to the conclusion that GALT most likely had the better treatment for liver fibrosis. That is why I did not invest in ICPT.
So now when GALT's Phase 1 shows significant efficacy, does ICPT sell off?
biotech said...
"Technical indicators are out the window for GALT at this point in time, anyone who followed them is just plain dumb.
BofA raised their target for ICPT this morning to $872 from $81, that is a market cap of over $8B
GALT may have the best in class drug for this treatment since it showed a reversal of fibrosis in pre-clinical trials.
If they hit their Phase 1 goals (a slam dunk since they've already done in for Davanat) you would think their market cap should be at least 10% of ICPT's, or $800M-that would be about a $45 stock.
Any demonstration of efficacy, particularly reversal of fibrosis, and this stock is north of $100 overnight."
You sound like someone without personal experience using the product. My wife and I have used the product for a couple of years and I think Leif's comments are quite accurate.
So there are now 20.7 million shares outstanding.
Questions:
1) Does anyone know how many GALTW warrants there are in existence?
2) I have never traded warrants like these before but I assume that the GALTW warrants are treated like options and are therefore not included as part of the outstanding shares. Does anyone know for sure?
I wish I started checking the MBs for all my stocks long ago. If I had, I would have known about GALTW and would now own a lot more shares with a basis of 50 cents or less per share. As it is, I had deposited additional funds to buy a few hundred more shares of GALTW and was waiting on the funds to clear. Unfortunately, they did not clear until yesterday and I missed the boat. Fortunately, I already had a significant position so I'm not going to cry...yet.
I disagree. I think that tox results are important because a proven safety profile should mean that Flucide can get approved for "expanded access" otherwise known as "compassionate use".
Once the product is curing flu patients who were otherwise on their death bed, I would think that "accelerated approval" should be a given.
Under these circumstances, I would expect see to see significant share price appreciation in 2014, certainly by the end of the 2nd Quarter of 2015.
But I claim no expertise that would give me special insight so this is of course JMHO...
arch433 said...
Human trials/success is the next catalyst.
Tox results will have little impact on sp.
Dead in the water for this year, $7 tops. ICPT type move if/when shows success in humans, 2016 looks like the proper timeline.
If not - $0.
At mid December there were like 536,000 shares short. The loss potential for them today was almost $110,000,000.
However, I'm sure most (or all) of them covered at some point today. Their buying of course pushed the price up even higher.
The patent news was 3 days ago so I don't think that is it. It smells like somebody found out some unpublished information and is trading it. But why did almost 40% of our fellow shareholders bail?
The volume of over 7 million shares is 49 times the 10 day average. That volume also represents 38.5% of the outstanding shares. That is a huge turnover in ownership!
Obviously somebody thinks we are going up from here. But where did that "somebody" find 7 million shares? The 60% increase today was nice, but it is nowhere near a selling point for me.
It appears that we have the ONLY cure for liver fibrosis! How could anyone who knows about the testing currently underway even consider selling now? But for some reason 38.5% of the ownership woke up this morning, and sold today.
I would have thought that it would have taken at least $50 per share to pry loose that many shares. WOW... Just WOW!
It's not even 2:00 and over 20% of the outstanding shares have changed hands today.
Up 30% on 25 times the daily volume and it's only 1:30. Something's up...
Amgen had $22.5 billion in cash at the end of the third quarter. They could pay $12.5 billion for Kevetrin and still have $10 billion left for "incidentals".
I would like to fly my Cessna as well, but flying a 172 from NC to Hawaii? Probably not... I still plan to see you there!
BK said...
The $20 party in Hawaii has never "went bust," only delayed, and now $70 per share with that same split adjustment. When it happens, I will fly myself there in my 510 Mustang.
My thoughts EXACTLY!!!
Leif said...
There was a reason why the founders of our country wrote this, in an amendment to the Constitution:
"Congress shall make no law ... abridging the freedom of speech." The law that grants the power to the FDA to stand between scientists, doctors, and health seekers is a clear violation of the Constitution.
People are being made criminals for stating true things in writing.
For the sake of the health of the American people it is critical that the liberty to communicate with each other not be infringed.
What STSI said about TBI was exactly the truth. It's not the business of the government to ban the truth.
Actually they are exempting the Anatabloc Cream. I tried to buy a jar and it said that the 30% discount did not apply. I did buy 10 bottles of regular Anatabloc and got the 30% discount.
Leif said...
This discount offered at GNC applies to all products for today only.
So you think that the chance is 80% that one department of a huge government agency, is familiar with specific information from several years ago from a different department?
I spent over a decade in a state government bureaucracy. My guess would be more like 50-50.
Another poorly researched "news" piece. This one was written by a lawyer. Some good comments in response to it though.
http://charlottesville.legalexaminer.com/uncategorized/star-scientific-under-scrutiny-by-fda-the-hits-keep-coming/#comment-3772
@Nuke John - I am pretty sure that I read somewhere (a few years ago) that the FDA made a determination that anatabine did not require approval as a drug before Star began marketing CigRx. Do you remember anything about that?
Perhaps we should make a FOIA request to the FDA?
ETA - I think I will wait and revisit the FOIA request after the conference call.
I seriously doubt that Star made any such claim regarding TBI. I strongly suspect that the only statements on the topic from Star were the PRs about the TBI studies. And those PRs did not make any such claim.
ASM Report Part 2
I have been trying to get the company's attention about declaring a product dividend. Back in early November I sent Talhia a long email on the subject. It took her a while to get back to me but she assured me that my information was forwarded to the appropriate people.
Before the meeting began, I was trying to find the company's SEC lawyer. (He was in attendance year before last and I remembered speaking with him then.) I asked about him with another Star employee and that person called him over. When I introduced myself, he looked at me and said, "You're the guy who sent in the information about product dividends!" I confirmed that I was and he replied that he had my information in his briefcase and that "it was going to be a topic of discussion at the BOD meeting that afternoon." During our brief discussion he confirmed that "product dividends" were a legitimate option. I gave him several copies of my updated two pager on the topic which he put in his briefcase.
Needless to say, the fact that he recognized my name, associated it with "product dividends", and had apparently done some preparation on the topic was VERY encouraging - to me anyway.
Of course when the BOD met that afternoon, they may have discarded the idea for some reason. But maybe not...
Here are the contents of the two pager.
December 26, 2013
To the Management and Shareholders of Star Scientific,
With the publication of the thyroid study, we have finally gotten the good news we were waiting on. Unfortunately, it appears that unless our management gets more proactive in addressing the huge short position our share price will continue to languish. That short position and the resulting active manipulation, misinformation, and slander is costing us. It's costing us not only in a depressed share price, but also in lost sales and unnecessary dilution. By unnecessary dilution, I mean that at $2 per, you must issue 5 million shares to get $10 million; at $10 per share you only need to issue 1 million shares.
What can management do? They have several options. The option I like best at this point is to declare a product dividend. As I understand it, that “product dividend” could take the form of a discount voucher good for products purchased directly from Rock Creek.
It would seem that declaring such a product dividend would be a win/win for Star and its shareholders. First, I think that getting more product into the hands of shareholders is a good idea. But more importantly, it may help address other significant issues for the company. For example, assume that Star issued a product dividend of forty cents per share in the form of a voucher good for an 80% discount on product purchased through Rock Creek.
Star has about 169 million shares outstanding. At forty cents per, it would normally cost Star about $6,760,000 to provide this dividend. But that is not really true in this case. The 20% that a shareholder would still have to pay (over and above the benefit provided by the voucher), should cover the company’s cost and then some. (If it does not cover the actually cost of the product, then we need to seriously review our cost structure.) However, we also have a wildcard that is guaranteed to pay off. There are currently 26,270,181 shares being legitimately shorted as of 12/13/13. As I understand it, those who are short have to pay the dividend for the shares they borrowed. That means that if they had to deliver those vouchers (only available from Star), their total cost would be over $10,500,000. That is a big chunk of positive cash flow that our company needs.
An additional benefit is that the shorts will not like it. Many will cover, which should drive up our share price. (Yes we could set the ex-dividend date as of yesterday if we wanted to and they would be stuck having to pay the dividend.) Further, once it’s been done for the first time, it would be easier to do again. Thus the threat of future product dividends would be a continuing disincentive to anyone thinking about shorting Star. (This should also shine a spotlight on any cockroaches who may be naked shorting our stock.)
Yes there are a lot questions to be answered before you pull the trigger on such a bold strategic move. And I am sure that the bureaucracy and the legal system will have “reasons” not to do it. But just like in every ultimately successful business venture, those “reasons” should be viewed simply as obstacles to be overcome.
Let’s make this happen.
Thanks,
Greg ******, Shareholder
<email address>
Here is a little supporting information (with cites) pertaining to product dividends…
Because that original investor who was kind enough to lend you the stock is no longer an actual shareholder with the company, the short seller is required to make up for any benefits the investor would have received had he or she actually still owned the stock.
In other words, if a company pays a dividend to shareholders, the second investor who bought the shares from the short seller would get the dividend check from the company. But because the original investor is no longer a shareholder of record (because the second investor owns those shares now), then the short seller must pay the dividend out of his or her own pocket. http://www.investopedia.com/ask/answers/03/122203.asp
A whole host of items can form the basis for your company’s next property dividend:
• bonds issued by the government;
• real property;
• the distributing corporation’s bonds, or another corporation’s bonds;
• assumption of the indebtedness to a third party of a shareholder;
• transferable vouchers enabling shareholders to receive company products or corporate services discounts; http://www.chochan.com/doc/taxletters/Property-vs-cash-distribution-from-Corporation.pdf
Definition of 'Property Dividend'
An alternative to cash or stock dividends. A property dividend can either include shares of a subsidiary company or physical assets such as inventories that the company holds. The dividend is recorded at the market value of the asset provided.
http://www.investopedia.com/terms/p/property-dividend.asp
ON RAISING CAPITAL...
The alternative below appears to be BY FAR the best option for raising capital by increasing the number of outstanding shares. If other companies can do this, so can we. There is no reason to have to issue warrants as additional incentive for investors to buy our shares. The attached PR shows how other companies are simply issuing and selling shares into the open market. If we do this after declaring a product dividend, the resulting dilution would be minimal.
25-Oct-2013 Entry into a Material Definitive Agreement, Financial Statements
Item 1.01 Entry into a Material Definitive Agreement.
On October 25, 2013, Galectin Therapeutics Inc. (the "Company") entered into an At Market Issuance Sales Agreement (the "Agreement") with MLV & Co. LLC ("MLV") under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0 million from time to time through MLV, acting as its sales agent. Sales of the Company's common stock through MLV, if any, will be made by any method that is deemed an "at the market" offering as defined in Rule 415 under the Securities Act of 1933, as amended, including by means of sales made directly on or through The NASDAQ Capital Market, the existing trading market for our common stock, sales made to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices, and/or any other method permitted by law. MLV will use commercially reasonable efforts consistent with its normal trading and sales practices. Each time that the Company wishes to issue and sell the Company's common stock under the Agreement, the Company will notify MLV of the number of shares to be issued, the dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters as the Company deems appropriate. The Company will pay MLV a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock sold through MLV as agent under the Agreement. The Company has also agreed to reimburse MLV for certain expenses incurred in connection with entering into the Agreement and has provided MLV with customary indemnification rights.
The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. …
Back@cha !
I very much enjoyed lunch and our discussion. Thanks again for lunch!
Sorry for the delay, but here it is...
Report on the Star Scientific Annual Shareholder Meeting December 27, 2013.
I did not take notes so this will not be very complete. Paul Perito conducted the meeting and laid out the plan for the leadership transition. Jonnie Williams was not there. Dr. Mullan made some brief comments afterward. His comments included the statement that next year’s ASM would be in Sarasota and that he planned to conduct a conference call in the 1st quarter. The ASM itself was pretty cut and dried and did not cover anything that we did not already know. They had the proxies necessary to carry the votes and even had the motions and seconds scripted. After the official ASM, Mr. Perito conducted a PowerPoint presentation, but I do not remember anything from the presentation that stands out.
Those in attendance had been asked to submit a question in writing. Yes we were limited to one question. Question forms were available at the sign in desk. Paul Perito read those submitted questions and either answered or called on other Star employees to answer those questions. My question was not among those he read, so I spoke up and asked it anyway. My question was, “Has there been or are we planning to do target marketing based on study results? (E.g. Are we or will we send copies of the thyroid study to endocrinologists, perhaps with some discount coupons they can pass along to their patients?) The answer was something to the effect that they have to be careful of promoting a supplement for disease treatment due to the FDA.
I spoke with David Dean after the meeting and he brought up my question again. I pointed out that in recent years the courts have not been favoring the restrictive stance that the FDA has against companies using published studies to support the sale of a supplement. His response was that since Star is going to the FDA for the approval of anatabine as a drug, Star does not want to create an unnecessarily adversarial situation regarding anatabine. That was disappointing to me, since I feel that this alone has the potential to put the company in a positive cash flow situation. (He did say that the cream will be a different situation because there is a different standard for products that are not taken internally. So it is very possible that once the rosacea study is complete we will see a more aggressive ad campaign for the cream.)
Additionally, I followed up on his statement about pursuing the IND with the FDA, making a statement about the S(-) isomer and he stopped me to say definitively that they were pursuing drug status for anatabine itself. I did not get to follow up on that but I suspect that it will be something like prescription strength Tylenol. And I thought about following up on the S(-) thing with Dr. Wright but he had participated via conference call and was no longer on the line.
I was listening to Mr. Dean’s response to someone else’s question and he talked about coming out with a “trial” size of Anatabloc for sale. I spoke up and voiced my concern that it takes 4 to 6 weeks to see results for some people. He replied that it was taking so long to see results because we still were not taking enough. I said well I take 4, 3 times per day. He said that was still not enough for someone my size. He said that the time released version will have 6 mg of anatabine that will release over 6 to 8 hours. It sounds like there will be an increase in the recommended dosage at some point.
He also talked about a self-sustained senior citizen’s community in Florida with about a 100,000 people. That community’s GNC has
Anatabloc sales of about 160 per month. Nancy Lopez has some connection to the community and he is planning a test marketing campaign to see how much they can increase the usage in that community.
I also spoke to Dr. Mullan after the meeting about when we might see an update on the Alzheimer’s study. He indicated that they have not yet had enough participants in the study. He mentioned the number 50 as the number so far but he was iffy on the number so I do not know how solid that is.
On tobacco; the statement was something to the effect that “If the FDA ever decides to use its authority to regulate modified risk tobacco products, then Star will be able to monetize their tobacco patents.” That is not an exact quote but I think it comes close.
It was disappointing that they were chintzy with the free samples. There were a limited number of bottles of Anatabloc, but no jars of face cream and none of the eye cream. They did have a limited number of the sample size tubes of face cream.
This is enough for one communication. I will follow up a little later with the skinny on the most encouraging thing that happened, so stay tuned…
Your Buddy is correct. Feuerstein makes money for his hedge fund friends/employers by generating FUD on small to mid-cap biotech companies. It makes perfect sense that he would create some cooked up crap of a formula to support his flawed analysis. As your friend pointed out; even when the small cap becomes a "big winner" by being bought out, Fraudsteins "rule" implys that you would have been a fool to have invested in it.
In this case, if PVCT is bought out for $10 billion a few months before Phase III data, the Fraudstein formula implys that owning PVCT would be a mistake.
There is also the fact that PVCT is already above his arbitrary $300M market cap. I would imagine that our market cap will continue to rise significantly higher before P3 results even if we are not bought out.
I think it's obvious that this "rule" tells you nothing important. it is simply a FUD generating tool to be used when Fraudstein is told to bring a company's price down.
@ North - Got the message. See you tomorrow.
Sounds good. See you there.
I'm 6 foot with short curly brown (graying) hair. How will I recognize you?
Please provide a link to the blog. Thanks.
Breakfast perhaps?
I agree with you. I was responding to the guy who said that no small cap company under $300m had ever brought a cancer drug to market. I was simply pointing out to him how close we are to exceeding his arbitrary $300m threshold.
evilbarbie said...
"Are you serious???? i will vote down anything under $50 ."
I believe I read previously (on this board) that such information is not available until 30 days after the meeting with the FDA.
kld2 asked...
"My question is the following: did PVCT learn from the FDA on Dec. 16 what route they specifically could take?"
With a share price of $1.75 right now, we currently have a $250m market cap. We only have to get to $2.10 per share to exceed your magic $300m. It's all relative...
kld2 said,
"...(Bringing a cancer drug to market) has never happened before with a (small-cap) biotech with a market cap under 300m."
I'm a few states south, down in NC.
From the proxy...
"The meeting will be held on December 27, 2013, at 11 am ET in the Mayfair Court of the Westin Hotel at 2350 M Street NW Washington, DC 20037. Please note that in order to be admitted to the meeting, all stockholders who own shares in their own names should provide identification at the check-in table and have their ownership verified against the list of registered stockholders as of the record date, October 30, 2013. Those individuals who have beneficial ownership of stock through a bank or broker must bring account statements or letters from their banks or brokers indicating that they owned Star Scientific common stock as of October 30, 2013."
Pipi asked...
"Do you know what time it starts and where in DC? I live in the DC Metro area."
Would you folks like to meet for supper Thursday night?
Is anyone going to the Annual Shareholders Meeting in DC this coming Friday?