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Budda,
Further they appear to show Osteoarthritis furthest along in the chart...so if it is just one this month for which they submit the IND, I suspect it may be that one.
OSTEOARTHRITIS furthest along on their development timeline chart. Would assume that this is the condition which they are targeting first with IND?
you said...<<IMHO, the March 20th presentation by Dr. Mullan told the big pharma companies what anatabine can do and how it it works. At some point, Big Pharma will pursue teaming arrangements (or an acquisition) with Rock Creek Pharmaceuticals. One of the most coveted drugs by Big Pharma would be one that regulates NF-kB activation and controls chronic inflammation.>>
While I have faith as demonstrated by holding/adding to holdings of this stock for the past several years, it is also somewhat perplexing that all of the scientific evidence has not led to a partnership for at least a single condition up to this point. Questions this raises to me. Lack of funding to accelerate development and progress is the biggest detractor to company's survival and growth. Raises the following questions at least for me:
Is the "scientific" evidence less compelling than we are led to believe?
Does RCPI believe it's better to wait to strike a partnership under better terms down the road?
Would RCPI be advised to make a statement that it believes its discovery is of more consequence than potential partnership opportunities currently contemplate?
There are 2 major factors to success...one is the great idea or product, the other is capitalizing at the right time.
What's there looks pretty good. Must still be "work in progress" though. Noted that clicking on "company profile" results in description in non-English (looked like maybe French). Other placeholders without final content. When going back to look again, looks like they rightfully denied access to these incomplete sections.
Hope the FDA simply "walking away" from its position doesn't imply that Star (Rock Creek) will need to go through un-natural gyrations to distinguish the drug version from the neutraceutical. Seems like this will potentially be a way for FDA to "save face" and cause future pain...?
Well...shouldn't be any later than end of July for FDA approval of IND if Mullan sticks to schedule projected during the investor day. He said target was to file by end end of Q2...and unless FDA responds to deny within 30 days, it's defacto "accepted" into Phase 1, correct?
All I can tell you is that I called the general number and asked for her...the operator referred me instead to Ted Jenkins email address. I questioned, "is she no longer at the company?"...and operator would not say (or did not know). I figure that she is likley out of the picture. Also, note that Ted Jenkins only name included on most recent PR.
They must of gotten rid of Tahlia Tuck?
No longer can contact. Good sign that they may be spending money more wisely...
My speculation...
Less advertising. Note cost of sales lower proportionally likely due to lack of advertising and using GNC as primary distribution channel.
I would also say that cost of Anatabloc along with avg consumer lack of disclipine to maintain constant dosage required will always be an inhibitor to sales growth.
Now if they get "endorsement" of the science and press around prescription versions for treatment of various conditions...AND Anatabloc is still available via GNC...then I would expect sales to increase again.
Hard to imagine...
RockCreek NOT partnering with another entity with $ for at least one condition...and SOON.
They need this validation and in the face of reduced neutraceutical sales, need something to reinforce "scientific proof" that they have something real and significant. If they can't get another entity to put skin in the game, we are left "hoping" that things change beginning 2015 when Phase 3 would prospectively begin, for a single condition? Gawd, I hope not!
Have significant $ invested in this...and still a believer, but Mullan must understand time not necessarily on his side...so if "science is on his side", he should be in position to convince a potential partner to join earlier rather than later.
Regarding Alzheimers...from the 10K for calendar year 2013...to compare/contrast to the just released 10Q for Q1, 2014...
The Alzheimer’s study that is being sponsored by Rock Creek and conducted at and paid for by the Roskamp Institute began enrolling subjects at the end of August 2012. As of March 1, 2014, 83 subjects had been screened, 62 subjects had been enrolled in the study and 53 subjects had completed the study. This study has now been suspended pending filing of an IND but an interim analysis is anticipated, the results of which may influence the decision to proceed with the study under an IND.
wouldn't it be nice if they DIDN'T wait until the end of the quarter? I know they are being careful/conservative, but hard to rationalize how it would take so long to have this thing ready to go. They should have been working on this for at least a year, if not longer.
A nice move would be to have it submitted prior to the end of May with a "no denial" within 30 days to mean moving on to next phase by the end of June.
And/or even better, announce more than 1 submission with perhaps a partner(s) on submissions 2, 3...etc.?
Getting a bit old giving these guys the benefit of the doubt.
Good post. I agree completely. I would "assume" that Dr. Mullan understands and has strong faith in Anatabine based on his experience and testing to date. That said, he DID remain CEO of Roskamp as well...which speaks to your concern about perhaps divided loyalties with the non-profit, altruistic, notoriety oriented objectives which his position to Roskamp brings to the table. Ultimately, hope it is win-win...but obviously, also want to know that he is "all in" with respect to Star (Rock Creek Pharma) stockholder interests.
Smoking cessation seemed to be another candidate for phase 1/2 that Mullan was signaling. Would seem to be a prescription version of CigRX?...maybe this is where the time release would come into play?
Obviously agree. I was simply pointing out that Star has done all possible to keep Anatabloc on the shelf. They don't control the FDA...
Perhaps you should take the matter of "dick moves" up with the FDA...
I have been prescribed 800mg Ibuprofen before...certainly doesn't mean I can't buy 200mg retail and just take 4.
But agree with some of your questions. Will be interesting to see how it all plays out.
Thought that was a rather interesting statement as well. My guess only is that this is what you get when you have a "reporter" writing a story. Also likely explains why you don't have the company referencing outside news stories on their own corporate Web page.
Can't understand any other possible reason that Mullan would make this kind of statement with respect to the FDA. (Only other consideration would be in reference to continued availability of the neutraceutical product...but that was not really its reference in context of article).
...and who is to say that first treatment pursued involves a "more powerful" version of anatabine?
How does one interpret this statement from Mullan from the article with respect to the FDA?
“They may say: ‘Look, it is in the food chain, it has been in an awful lot of people. We haven’t had any serious adverse effects directly attributable to it,’ ” Mullan said.
This seems to speak directly to the safety profile. Does this mean that Mullan believes there is a chance that they could move to Phase 2 earlier than 2015?
Ok. So care to explain your original comment,which makes no sense regardless?
"Sounds like they are trying to decrease the market value of these warrants for tax purposes."
Huh?...
Warrants would not be taxed until exercised regardless. So this appears to be nothing more than a win-win for Star. Simply appears to be an accommodation by the warrant holders and endorsement of giving Star lots of runway/flexibility with respect to returning value. BTW, the original exercise price of the warrants was $1.80/share. Nice to know that if Star stock price rises significantly over next many months to make these warrants "in the money", that there will be no concern about immediate conversion.
And if they do, I see good "negative press and publicity" aimed at FDA as a result that will raise awareness/press of Rock Creek. If they don't, then sales continue and will likely increase over time as prescription version works it way through phases with resulting publicity. I view as potential win either way. Won't bother replying to your reply further based on your track record.
Retail Anatabloc. Will be interesting to see what kind of "news and press" gets out for Anatabloc over the next 18 months. Assuming that Anatabloc neutraceutical does NOT get pulled (and I have hard time believing FDA will pull after this amount of lapsed time and Star's response), would expect that Abloc sales will go up as more word gets out. And if they DO pull it, that will be worth substantial publicity as well. I would imagine first scenario would be better for near term stock price, but mid-term, who knows?
Starting anew...
After watching/listening to replay, I have to believe new management taking this as opportunity to lay out the foundation for attracting new investors and future appreciation. And as expected, they are being conservative. And obviously, they will need partnerships and funding to get to Phase 2 early next year.
I certainly HOPE that the many PHD's at RC/Roskamp have been making further scientific progress as related to their own testing of the science and MOA for anatabine...some of which has not been shared. (Most of what was presented by Mullan was known and already covered many months ago).
It seems to me that they are playing it as safe as possible with respect to the FDA...and cannot reveal but so much until the FDA "green light". And to the FDA, the main issue here is how do we deal with the dilemma of:
1. Taking supplement away from loyal users who claim to be seeing great benefit.
2. Leaving supplement on market (even without marketing) prior to safety being formally validated by Phase 1.
My guess is that Star is willing to accommodate FDA to an extent in order for FDA and Star to "save face"...so that both can live with consequences moving forward.
As to the conference performance, I was impressed as usual with Dr. Mullan. Dr. Chapman and CFO not as much. But hard to know how good or respected they may be based on this dog and pony show alone.
Hope that Star has some surprises "up their sleeve" with respect to revealing further evidence of MOA, etc. that will cause potential partners, etc. to take notice!
Can't afford to live in a complete news vaccuum between now and launch of Phase 2. (yes, they likely can from financial perspective...I am talking Shorts/manipulator perspective...although I am guessing longs will not be selling regardless...certainly, that is my position)
Hope considerable progress is reported during next Wednesday's meeting on the science/testing front.
While I know that much of this is about laying out a course and updating potentially new investors, it would be very disappointing if there is not new progress beyond the study results, etc. published months ago.
RCRX might be even better but assume not available?
Ted Jenkins sent email inviting contacts to join next week's Webinar. Would imagine that will get alot of Wall Street folks to watch.
This provides some background...
http://health.heraldtribune.com/2013/02/25/test-can-measure-your-brain-reserve/
My guess he's feeling just fine vs. people who bought at 2 or 3 or 4...!
And surprised that this close to major event next week that stock trading where it is.
Is the study referenced in NukeJohn post likely the time release version of OTC Antabloc? If so, does this mean they at least have all the participants they need? Would like to think they would be somewhat further along with this....
have approaching 200K shares. certainly not "bragging" about that fact...and not much to "brag" about anyway. But also, with no intention of selling based on FUD. Does make me consider that there are other retail investors like me who have similar attitude and certainly brings credence to the wonders about how many "naked" shares are out there.
Very prudent and pragmatic suggestions in that reply. Of course, the FDA should also feel some accountability for the inconsistencies that Star's response points out clearly. Or are we expected to be so conditioned to believe that big brother is ALWAYS right, no matter what they say?
I'm always amazed at folks who claim to be in constant pain and then don't have the discipline to take meds/neutraceuticals (even if it is 4 or 5 times a day)...also, lots of folks look for instant results.
Ultimately, that's why time release version will be important...as well as medical "buy in"...
I find it interesting when disussing with doctors and other medical professionals who have not even "heard" of Antabloc. A good reminder that even though you don't want to be a self-diagnoser, you also are ultimately responsible for your own health!
Also "guilty" of buying extra. Also, think that this situation makes it even more likely that you "give" a bottle to others to try. I know in my case, that has been true.
Also to the point...from a "NukeJohn" post and PR last year...not a "safety guarantee" but you can bet important to athletes and another data point...
"Isner's decision to become an Anatabloc® brand ambassador coincides with the Company's results of testing from HFL Sport Science, one of the leading organizations in doping control and research. HFL Sport Science batch tested Anatabloc® for the presence of a wide range of more than 147 prohibited substances using HFL's ISO17025 accredited nutritional supplement screens. The testing found Anatabloc® to contain no banned substances."
Then by all means makes sense. But I also think that a big potential market for Anatabloc is "preventive" therapy in nature. That is, if it can keep inflammation "in balance", might be good to take for all number of future possible conditions and/or keep them from developing in the first place. That is one of my rationale's for taking it currently. And that's where I believe the time release version will make this option more realistic for the average consumer.
Wonder if time release version is still on track for this summer?...and will it be OTC? That is one reason I would have for holding back on stocking up "too" much.
Expectations for March 20?
What makes it a "success"? (aka stock goes up from where it is now...and how much?)
vs.
What makes it remain where it is or go down?
That, obviously, is the question.
Would be interesting to get different perspectives from board community on this.