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FDA imposing its relevance?
Again, how many products are sold as both an OTC drug (or neutraceutical) AS WELL AS a prescription drug. Not many, I don't believe...all I can think of are prescription strength Tylenol w/codeine (different from OTC Tylenol anyway), 800mg Ibuprofen (why bother, just take 4 of the 200mg...unless you get cheaper as prescription).
STSI already announced that they would be pursuing 2 different paths...one prescription, one neutraceutical.
The FDA letter may be as much an attempt to reinforce its relevance as anything else. The drug "cocktail" notion that many predict for Alzheimers treatment (w/Mulan and the Phase 3 trial going on in Europe) offers the potential that Anatabine is included in the prescription version "cocktail"...again separate and apart from OTC Anatabloc. I would think Anatabloc inclusion for treatment of other conditions would follow this path as well. I guess my point, the FDA needs to be able to clearly make a distinction between OTC and prescription products. Star cutting back on any specific medical claims for the OTC version helps keep such a distinction in place.
And so what? Smart consumers will be able to figure it out. Doctors will become more aware. Spokespeople like Couples and Lopez (and hopefully others) will keep Anatabloc OTC moving nicely while the more lucrative prescription market develops over time.
naysayers, shorters will be very nervous leading up the call on January 15. New CEO could say something that could cause this thing to jump considerably...not predicting it, just a possibility. His preference may have been to hold EVERYTHING off until the 1st quarter update, but I suspect that some of what was planned for that session may now be covered during the January 15 call. Hmmm...new CEO and first general public call in say....EVER! If I were shorts, I would be VERY VERY nervous. Our new leader may be realistic...but I also would not expect him to put a NEGATIVE spin on the company's prospects. You think he's going to say something that will cause it to go DOWN further?...always possible, but I would certainly bet more on the opposite.
Agree. In spite of my rather hostile posts otherwise. The beauracratic delays and lack of accountability of government organizations ultimately is rather disturbing. But that's a political discussion that I will not get into.
Thanks for your post. Nice to hear from someone that was actually at the meeting and can provide a feel for the "between the lines" sense of what is really going on and personalities, etc.
Give me a break!!! er...Washington Post....Virginia governor race...you do realize the FDA is based in DC, right? Star very well may have not followed proper protocol, but "under the radar" is preposterous.
What do you mean by "current fiasco"? You mean, the FDA calling into complete question that Anatabloc should be considered a lawful neutraceutical? Well, what Star has been doing from a PR, Website, studies, retail perspective has been going on for a couple of years now. The "fiasco" part is the FDA...very, very late in the game...suggesting that ALL of this was improper and should be unplugged. I would think that the FDA, if smart, will work with Star to find a compromise to keep Anatabloc on the market. In some respects, it might be better for it to be pulled (from an investor perspective), to bring more attention to the need to fast-track a prescription, properly regulated version.
This is more about the FDA really not knowing how or when to regulate neutraceuticals and indiscriminately deciding when and how to enforce their power. Even if you believe Anatabloc is "snake oil" you should be outraged at the FDA's failure to bring its objections to the forefront MUCH, MUCH sooner than they have. All of which leads to questions about corruption, big Pharma influence, etc. That deaf, dumb and blind kid sure knows how to play a mean pinball.
Saw note from one of the people attending who suggested that someone from the company indicated it would be available in Summer.
Pretty pathetic. FDA claiming that they can't be expected to keep up with 85,000 neutraceuticals. Well, GNC, the biggest neutraceutical retailer in the USA made Anatabloc its "product of the year". Then, although they throw Anatabloc under the bus on TBI (well...was it the Dept of Defense or Star?), the letter they sent basically trashes everything that Star is about. Have they been asleep at the wheel for the past 2 YEARS!!!??? That is the damning take-away with respect to the FDA to me.
Leif,
I believe there are shades of grey in the retail numbers. I certainly have re-ordered and continue to use. Have also purchased for friends and relatives...most recently for my 83 year old mother who reports good results relative to knee and joint pain. Price is a challenge but more importantly, personal discipline to take the number of times required daily. Lots of folks lack that discipline...even those who suffer from maladies who can actually be helped.
The time-release version should help.
Leif,
Appreciate your position and VERY relevant observations. Just know that you are not alone with your opinions...
My biggest concern is that STSI (or whatever it becomes) has the chops to wade through all of the crap that can get in the way. Hopefully, our new leaders are up to the task.
Yes, thanks. P.S...while appreciating his "enthusiasm", NukeJohn credibility suffers when he refers to things that simply aren't there in fact or cannot be confirmed.
You said,
"They appear to be ready to hit the ground running with upcoming investment conferences and discussions with Pharmas."
What exactly are you referring to there? I know they said they would have an investor update in Q1, but is there something else that you are specfically referring to?
Certainly wish I could be there myself...but appreciate you and others being there to report back to the rest of us!
Will be interesting to see how much you can learn. My fear is that they will point to some update in Q1 (already referenced in the news release) rather than say much of anything now. I wish these guys would move a bit faster in revealing their plans!
Well...sounds like this may drag out even longer. Of course, Governor/wife and their lawyers throwing everyone else under the bus. Good to see that Sutherland appears to be a "threat" to the govenor/wife credibility...so it's not just J Williams whose "credibility" is being questioned.
Dec 27 date of annual meeting.
What is date of annual meeting? Thanks in advance.
Why change the retail price now?
STSI has clearly stated that plan is to emphasize pursuit of the prescription version(s) of Anatabloc as the most lucrative path. For now, at least you might as well keep the price high to reinforce its "worth". When/if enough consumer/market buzz is created around Abloc to make a big difference in retail potential, then you re-evaluate your options. But not until then. My guess is that STSI does want to keep retail alive and viable due to value of loyal customer base, commitments to GNC, and as a hedge against FDA approvals/pharma partnership potential going smoothly.
Sufficient funding through Q3, 2014...also takes pressure off!
From 10Q...
" We currently believe that, after giving effect to the financing related transaction entered into on November 7, 2013, we have sufficient funding to support our operations through the third quarter of 2014. "
Time Released version of Anatabloc already developed...per 10Q, just needs to go through full testing.
So what's the testing strategy moving forward? Why is/was there no formal study underway for longer term evaluation of Antabine for Thyroid beyond the 90 days? Hope we don't have to wait another 2 years for next study to be initiated and peer reviewed...suspect/hope we something in next week's 10Q.
"We believe that continued supplementation (beyond the three months of this study) will show a progressive improvement in overall autoimmune responses."
Excellent post and reminder.
A useful link. http://www.thyca.org/pap-fol/more/thyroglobulin/
I am merely a layman with no scientific background, but Itake reading information on this link to mean that the sentence directly after the "however" in "results" from the peer review report is very positive for Anatabine (and Star). The shorts/contortionists (aka serial loser NOMO) are trying to play the word "however" as some indication that it is delivered in the context of "here's the good news..."however" here's the bad news." A very simplistic, non-scientific comment by a a manipulative dummy.
Also, imagine that Star has not been "sitting on its hands" since the initial study was completed many months ago.
Dr. Wright makes the statement, "We believe that continued supplemenation (beyond the three months of this study) will show a progressive improvement in overall autoimmune responses."
Question is, will we have to wait on another "peer reviewed" study to back up his statement? Has STSI already initiated a formal, longer period study?...if not, why not?
Some scientific, researcher interpretation of results required...based on the stock price reaction, appears to be slightly positive...but why the muted reaction?
Is this the "use" patent you are referring to?....this from September, 2013 Star PR. They said it would likely take 60 days to formally issue.
"The allowed '295 application discloses an improved process for synthesizing anatabine that facilitates larger scale, commercial production, as well as novel salts of anatabine including anatabine citrate. An initial patent, U.S. Patent No. 8,207,346, based on the same disclosure, was awarded on June 26, 2012 and covered claims for the improved process for synthesizing anatabine. The claims allowed in the '295 application cover anatabine citrate per se as well as formulations containing anatabine citrate. The company, through Rock Creek, continues to pursue several additional patent applications covering dietary formulations containing anatabine, and methods of administering anatabine for the nutritional management of disorders associated with unhealthy levels of inflammation."
Brett Favre might make a good spokesperson for Anatabloc.
Obviously, he comes with a bit of baggage, but his memory loss revelation is certainly getting lots of exposure. And everyone knows who Brett Favre is...
This would seem to be the key line, taken from the abstract of one of the 3 presentations referenced being done at the Neuro Conference in November: but seems as though we need interpretation of the actual presentations by scientists/medical to determine whether this is good, bad, and/or somewhere in between...
"We propose that anatabine has biphasic effects, acting on nicotinic receptors at µM concentrations but directly blocking NF-?B at mM concentrations, which depending on context, may lead to cell death."
Certainly no answer, but below may be piece that helps? First time posting here so don't know whether this will work below...
[url]diffen.com/difference/Apoptosis_vs_Necrosis