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If this were "industry" as opposed to "government", I would suggest that RCPI is doing a good job of requesting the FDA as to "what exactly do you want us to do?" with regards to supplement and/or new drug applications. Of course, in "industry" you would expect some clarifying response to any/all questions posed...but, of course, this IS "government"...so is there any real accountability?
So when do we find something out? RCPI update from 3 weeks back suggests that FDA will provide a response to NDIN...when?...and is the data that RCPI provided the same as it has to provide for the "objections and/or missing information" that FDA requested for IND? Still lots of questions...but seems that soon RCPI should be advising on specifics. What obligations does FDA have timeline wise for the NDIN?
From previous Rock Creek update:
"In addition, the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program."
Response from FDA to my inquiry:
The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number xxxxx.
Response:
Thank you for taking the time to contact the U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN). I am able to provide you with information available at www.fda.gov that will direct you to the resources, guidance and regulations that will assist you in determining how to apply them to your unique product, circumstance, question or concern.
You may find it beneficial to review all of the information provided about dietary supplements.
For information related to Anatabloc, you will have to contact the manufacturer directly.
Dietary supplements are not FDA approved, as FDA does not approve or test dietary supplements or their ingredients for safety or effectiveness before they are marketed nor does the agency conduct testing at the requests of consumers. However, the agency has the authority take dietary supplements off the market if they are found to be unsafe, adulterated, or if the claims on the products are false and misleading.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), requires manufacturers to ensure that their products are safe and properly labeled. Properly labeled includes labeling that is truthful and not misleading, which provides ingredient and nutritional information.
To learn more about FDA please visit: Center for Food Safety and Applied Nutrition (CFSAN), Contact FDA, Submit Questions and Comments, Print Publications, Is It Really FDA Approved?, What does FDA Do? and What doesn’t FDA regulate? How do I contact the agencies that do.
Thank you for contacting FDA’s FCIC.
**Please do not reply to this email box. If you would like to submit a follow-up question or need clarification to this inquiry, please click here http://cfsan.force.com/Inquirypage and reference this inquiry’s case number.
Interesting article regarding Eli Lilly pursuit of "autoimmune" drug market. Think there is not some interest in seeing RCPI progress stopped?
http://www.ibj.com/eli-lilly-making-renewed-push-in-biotech-field-where-it-once-pioneered/PARAMS/article/49069
For those that scoff at "mouse study results", found this exerpt from the artcle especially interesting.
""Roughly a year after Lilly halted its autoimmune research effort, researchers in Greece demonstrated for the first time that biotech proteins slowed the progression of rheumatoid arthritis in mice.
That breakthrough led to the first successful human trial of a biotech autoimmune drug, the results of which were announced in 1994 by Pennsylvania-based biotech firm Centocor. When Centocor’s drug proved effective in 19 of 25 patients, it knew it had something that worked.
That drug, launched in 1998 as Remicade, became the first of the new wave of autoimmune drugs.
“That was the big tipping point, the big ‘Aha!’ moment,” Bumol said of the work that led to Remicade.""
Send note to FDA requesting status. Can't hurt...I did so today via their Web site and was issued a case number.
Although RCPI product pull was voluntary, they "pulled it" due to no clarification or approval from FDA.
They should at least be made to feel that there are people who care.
Yes, agree!
But also wonder, since Dr. Mullan serves as both CEO of RCPI and continues to be head of Roskamp...it makes me wonder about any appearance of conflicts of interest as well as potential synergies. Your thoughts?
So, does RCPI have patents for synthetic manufacture of (or pending patents) with respect to BOTH "anabasine" AND "anatabine"...or just antabine?
In the radial-arm maze memory test, anabasine but not anatabine significantly reduced the memory impairment caused by the NMDA antagonist dizocilpine (MK-801). In the signal detection attentional task, anatabine but not anabasine significantly attenuated the attentional impairment caused by dizocilpine.
bhp1rtp, agree with "seek the light". You post very good stuff.
Thanks!
Contrary to what others may say,
Anatabloc DOES work...likely not for everybody, of course. And my guess (as good as anyone else's) is that its lack of success in retail is mainly due to:
1. Consumer lack of discipline to take something that frequently and consistently during the course of a day...and day after day.
2. Price.
If additional evidence is reported in upcoming trials of success for treatment of any/all conditions being tested, then that chganges the dynamics for both 1 and 2 above. A time release version will certainly help as well. Whether this comes in the form of both neutraceutical and/or prescription of course is TBD.
Bottom line is this.
Anatabloc has not been making the company much $ to this point.
RCPI is making it known that FDA is guiding their actions now (whether that is explicitly stated by the FDA or implied by FDA not providing a "green light"). Either way, in my estimation it puts the pressure, if there is any, back on the FDA. I believe there will be some pressure from loyal Anatabloc users with respect to the FDA. And this is good.
If neutraceutical IS made available again, a nice PR potential...almost a re-launch for RCPI. (obviously, with whatever restrictions in terms of claims that are kosher with Almighty OZ...er FDA). (much like Oz, likely a bureaucrat hiding behind a curtain).
The big prize still prescription version...whether via Europe and/or the USA...hopefully BOTH.
Not surprisingly, I couldn't disagree with you more!
Glad RCPI appears to be looking out for interest of shareholders first. Ultimately, this will also be for the greatest benefit of Anatabloc loyal users...who will be best served by the company surviving and thriving.
You must have RCPI confused with a non-profit?
And btw, RCPI appears to have tried its best to meet the rather convoluted "requirements" of the FDA. At some point you have to "punt"...if the FDA ends up looking like the antiquated, progress-hindering political organization that they are in the process...so be it.
Just went to the local GNC (an independent store, not company run). Manager had just removed Anatabloc from the shelf...said he received the recall email this morning. He told me he could be fired if he sold it to me since he was in receipt of the notification.
I believe a smart move on RCPI's part, if only to put some of the pressure back on FDA to "get off the pot". I hope things are resolved in the near term for those that are running low on the product. Perhaps the negative publicity from this (for FDA) will provide some incentive for them to "do the right thing"...or at least be more aware of expediting approval(s).
FDA's "comments" prior to approval for Phase 1.
That was about a month ago now that we learned of this from RCPI. Isn't it about time that we be given some idea of what the holdup is?
Really like this announcement. Also wonder if it may also be an additional security blanket with respect to confidence (or lack thereof) in Chapman and Jenkins. Chapman may have bumbled a bit of the FDA submission?...Jenkins maybe without some of the chops required to help as much as required with the Wall Street crowd.
Again, not trying to throw cold water on a positive announcement, but worth at least speculating as devil's advocate. Of course, these are board members to assist with strategy, oversight, etc....not necessarily active participants in running day to day operations.
Thanks for the clarification. I guess we are left with at least the potential positive reference for tobacco...and maybe it makes tobacco's association (even if by name only) with anything that RCPI is pursuing more acceptable to the scientific/medical community/public.
Yep. Gotta believe that this will get people "noticing" that there may be something "good" in tobacco...at the very least. And as I recall, although largely similar in chemical makeup to tobacco (sorry, probably wrong nomenclature...I am not a scientist), anatabine is still slightly different and without the harmful components.
BTW, I will admit to be a layman. But I do read things other than entertainment political blogs. I wonder if people laughing at "tic tac" man would also be laughing about a potential cure for Ebola virus.
I also don't want to draw any firm conclusions...BUT..certainly worth noting and continuing to follow this story line. A subsidiary of Reynolds American (btw, Reynolds American the same company that STSI settled with for 10M in non-exclusive)...
We all know the STSI (now RCPI) story and its originations from JW's tobacco experiments with microwaves.
Maybe the "tic tac" man has something afterall!...and maybe the government health official should open her mind up a bit more the next time instead of blowing off ideas that could one day save her poor mother. (for those following the blog of the trial, you know what I am speaking of).
Likely. But will they sue JW or STSI (now RCPI)? And how does patent ownership play into this? We all know that in any shareholder lawsuit, only the lawyers make something. And concern would be that it appears that JW is RCPI's primary benefactor. Would certainly hope that when the smoke all clears from this trial and is behind us, that more interest surfaces in this company and the "big science" that it is supposedly sitting on.
Also agree. Would be interesting to get some insight as to what exposure RCPI has for potential JW stock transfer transgressions. Also, remember that JW was the $ behind the last funding injection (as I recall)...and he is the name associated with all of the patents.
All that said, alot of this now is simply the Feds ensuring that they "look good" on follow-through with toughness toward Gov/Gov wife...otherwise, this will look in retrospect largely like a political witch hunt...which of course, it was.
Funny, in a sad way, that JW is forced to take such a hard line that he expected to "get something" in exchange for his "friendliness" toward the Gov/Gov wife. As if the distinction between friends and business is so clearly defined...what a crock of BS! I guess every business man who buys lunch for a client is similarly guilty!...or every time Hilliary and Bill collect huge $ speaking fees...or a wealthy person contributes to a PAC (politically acceptable "bribes")...the list goes on and on...and it's not necessarily a Dem/Repub issue...but the unfortunate way of our world.
Good thing the FDA is all about science, truth and justice! ;-0
Politics. That's an easy one. Now back under the rock!
3 weeks later and nothing from FDA? I am guessing this agency may be run like the IRS. More politics?
Ted Jenkins should have someone proof his public comments...I assume his use of "duel" was intended to be "dual". That said, maybe he is suggesting a "duel" between Europe and US FDA in terms of whether they will allow politics and beaurocracy stand in the way of medical progress.
Good move, obviously to also have a European strategy for drug development. Provides at least some backup to whatever goes on at FDA and hopefully opens a parallel path for treatment of conditions other than those first targeted in US.
Would largely agree...except for perhaps the request to buy the watch by the First Lady...paying for the daughter's catering at wedding reception also a bit stretching it. But I really blame the Gov's wife and to a lesser extent the Gov. Mostly for being stupid.
All too convenient for the casual citizen to be easily convinced by the PR that everything ALL BAD. Meanwhile, the new Gov has been much more adept at cloaking his indescretions and for many more $ over the years.
Had the political machine not been so aggressive about convincing JW that he was in "big trouble" (in exchange for immunity), I could easily see where the defense would be..."so what, we are friends", and btw, "what specific favors resulted for JW and his company?". The answer: absolutely nothing. Would still expect the latter to be a part of the defense.
My guess is that the "news" is already largely out there. There is not going to be a letter that states, "Governor's wife lady, if I buy this watch for you to give to the Gov, will you promise to get me some meetings with important people in the state of Virginia?".
The soil has already been out there...it's just going to be re-hashed again.
Still not sure I see it as much different from "lawful" lobbying...the guy that steals from grocery store shelf gets 5 years in prison...the guy that takes a $1M donation from PAC to spend on his political campaign gets "elected".
Patent application title: METHODS OF PROVIDING ANTI-INFLAMMATION SUPPORT
Publication date: July 24, 2014
Filing date: January 29, 2014
http://www.freepatentsonline.com/y2014/0206656.html
Worth reading and reviewing details.
Thanks to a_brown3 for making aware of on another message board.
Good stuff...thanks for posting.
Nice find! Thanks
Wonder if the "big boy" pharma companies typically report on simple notification of a "pending comment" from the FDA on an IND application?
Guess maybe it depends on how significant it is to that pharma's overall business?
Also, wonder if this is more about RCPI working to be as transparent as possible?
Or maybe RCPI feels it is in their best interest to be transparent based on FDA's "last letter of reprimand"? Maybe this is something that RCPI was hoping could have been clarified prior to IND submission which was why they waiting as long as they did to file?
Just guessing, of course, and throwing stuff against the wall. Hopefully, we see something from FDA in next week or so...
"Here Comes the Judge"...er FDA.
ARASOTA, Fla., July 11, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc. (RCPI), an emerging biotechnology company, today announced that the Food and Drug Administration ("FDA"), has notified the Company that the agency will provide comments on RCP's Investigational New Drug ("IND") application before granting the Company permission to start its clinical trial in the US.
.
Rock Creek Pharmaceuticals
Dr. Chris Chapman, RCP's President, commented, "We appreciate the agency's review and comments on our IND. When we receive the agency's official comments and/or recommendations, we will respond expeditiously. We look forward to moving this important product through the regulatory process."
Major Alzheimer's Conference in Denmark over the next week. Being covered by CNBC...and will be next week as well.
Surprised if Mullan is not there.
Lorillard and Reynolds in merger talks. Wonder what thet means, if anything, as opportunity for RCPI in terms of their settlement with Reynolds?
Exerpt from FDA site...
"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
Where did you come up with 60 days on IND approval?...I believe it is FDA must issue questions/objections within 30 days of submission otherwise move to Phase 1 is defacto approved.
So now we wait. (wonder if IND was submitted yesterday or previously?). (And wonder if it WAS submitted yesterday, RCPI was hoping for some guidance/resolution of reconciling neutraceutical vs. IND prior to submission with FDA).
Seems as though same questions outstanding. Is neutraceutical allowed to continue along with IND acceptance?
And if no word from FDA after 30 days of IND filing, we are good to go with Phase 1. Would this also mean that FDA has in effect also tacitly indicated that they will not force neutraceutical off market?
And what will distinguish the neutraceutical from the prescription version being contemplated from a science perspective?
Interesting also stated is "Target disease evaluation - Under review". Wonder if this means the IND was not filed for just a single condition?
8K filed. IND filed and under review.
Obviously, certainly hope what you say is dead on!
Will be interesting to see if the IND filing (or more relevant, the acceptance by FDA) has any impact on availability of retail Anatabloc. If there is any chance that RCPI would accept a "compromise" to take it off the market, hope that they would get in exchange for agreement by FDA to fast track IND. Not sure it works that way...but would like to see others' comments.
How complex is the MOA of Anatabine? Have the visiting researchers who have been to Roskamp not been exposed to this revelation? Is RCPI waiting until the IND is accepted to begin the full assault on Wall Street and the pharma industry to present its signficance?
Not trying to be a nay-sayer here...just trying to reconcile why this has taken, and is taking a LONG, LONG, LONG time to develop.
And the research has been ongoing for years even while Johnny and others at the company may have been tripping with respect to strategy. I am certainly willing to believe in the new management (is there a choice?)...but it is perplexing to me that the significance of the science here is not already perceived by those in the research/pharma community.