"Was Maureen McDonnell doing Jonnie Williams?"
THAT is the latest news article? doing? wow.
if maureen had a crush on jonnie ~ we go up 5 cents
if maureen made love with jonnie ~ up 10 cents
if maureen was doing jonnie ~ up 20 cents
if maureen becomes redskins cheerleader again ~ down 10 cents
Patent application title: METHODS OF PROVIDING ANTI-INFLAMMATION SUPPORT
Publication date: July 24, 2014
Class name: Drug, bio-affecting and body treating compositions designated organic active ingredient containing (doai) 9,10-seco- cyclopentanohydrophenanthrene ring system (e.g., vitamin d, etc.) doai
Abstract: This disclosure provides products, including pharmaceutical compositions and dietary supplements, which are useful for anti-inflammatory support.
Products comprising a compound of Formula I (e.g., anatabine), described below, and vitamins are useful for anti-inflammatory support. "Anti-inflammation support" as used herein includes helping the body to avoid excessive creation of inflammation, helping the body maintain lower levels of inflammation, helping the body maintain healthy levels of C-reactive protein, and the like. Products described herein can be, e.g., pharmaceutical compositions or dietary supplements. "Dietary supplement" as used herein includes the type of product identified in the United States as a "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994, as well as the type of product identified in other parts of the world by terms such as "food supplements," "nutraceuticals," "functional foods," or simply "foods."
Products disclosed herein, including pharmaceutical compositions and dietary supplements, can be provided for administration to humans as well as to animals, such as a companion animal, a service animal, a farm animal, or a zoo animal. Such animals include, but are not limited to, canines (including dogs, wolves), felines (including domestic cats, tigers, lions), ferrets, rabbits, rodents (e.g., rats, mice), guinea pigs, hamsters, gerbils, horses, cows, pigs, sheep, goats, giraffes, and elephants.
we need someone with integrity. a president, governor, what have you, who is actually honest regardless, above reproach, and who is unwilling to compromise good morals. I might suggest ben carson, but I'm afraid that may be a bit too political for a stock message board...so I won't. :)
I also find it just as interesting that a pr was even issued today. if negative, it seems a pr might be held off until the negative news was official. if positive, all the more inclination to pr now...imo.
"the Food and Drug Administration has notified the Company that the agency will provide comments on RCP's Investigational New Drug application before granting the Company permission to start its clinical trial in the US."
I find interesting it says, "before granting", and not "before possibly granting" or similar. perhaps I'm reading into this, but I feel precise wording here is paramount.
Phase I should be complete, or almost complete by year end, determining safety, as well as deciphering what the body does to get the drug out of the body...drug absorption, drug distribution throughout the body, drug metabolism, and drug elimination.
Phase II planned to begin 1st qtr 2015.
The subtle edge osteoarthritis boasts in the pipeline chart suggests a slight lead in initiating its clinical study, just ahead of smoking cessation and hashimoto's thyroiditis clinicals.
ANY day now.
Like John Glenn and the Beatles, the sixties will soon be but a memory.
interesting read in the good book today.
Deuteronomy 28:15,22 -- "if you do not obey the Lord your God...all these curses will come upon you...the Lord will strike you with wasting disease, with fever and INFLAMMATION..."
written about 3420 years ago!
disease largely 'caused' by inflammation
anatabine reduces inflammation (and even crosses blood brain barrier)
proposed reduced tissue damage and reduced brain (organ) dysfunction
anatabine appears non addictive
positive results in mice
positive results in numerous humans thus far
positive published results
safe and well tolerated by "several hundred thousand users"
clinical targets selected...three potentially close to phase I studies
patents / incredible market potential
professional and qualified management team
dr. chapman ~ was senior director of medical affairs with quintiles where he oversaw new drug apps, clinical studies, and submissions to the fda for approval
ind filing currently under fda review
target disease evaluation currently under review
phase I study may begin 30 days after ind filing (if not rejected)
when was ind filed? 5 days ago? 30 days ago?
certainly more eyes when phase I initiates.
today...seven shares for the price of a latte.
"Upon receipt of the IND submission by the FDA, the investigator may proceed with the clinical study 30 days after the receipt date on the FDA’s IND acknowledgement letter (unless notified by FDA not to begin the study) OR on receipt of an IND approval letter from FDA."
"Clinical Trials--Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research. IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study's objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm."
"Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80."
pr for new ceo using newly installed urinal? not worthy.
pr for an ind filing? not worthy, imo. not yet. let's get APPROVED first.
pr to begin Phase I study? definitely.
the more subtle, calm, and professional approach of informing about the ind filing. they are not trying to hype it to gain a few pennies, to possibly watch it dribble back down again until the next news. they said they intended to file an ind in the second quarter, and they followed through, as well as letting us know within one day of the end of said quarter. they've trimmed some fat on payroll expenses, I believe, and also by moving most of the company down south for better synergy.
sometimes less hype is good. keep it professional. less circusy. stay focused on the goal. the 8-k was more transparent and informative.
well done, I say.
to be expected, already a thumbs down. not only do few understand it, few LIKE the notion of a holy God. it's ironic, for a holy God should be desired. an unholy God would be frightening, unreliable, and chaotic. i would not sleep well if that were the case. anyway, the point in the matter is that the stock manipulators will receive their due reward in time.
but only temporarily.
it matters little if it's theft or manipulation in the market, cheating, adultery, lying...there's always consequence...ALWAYS! many believe they'll never get caught. one ALWAYS gets caught...even if no one finds out. karma is simply a word in the place of God. 'karma' will get you.
few understand this concept. God is holy. completely holy. nothing else tangible in this world is holy, except his Word. we take that for granted. he cannot allow sin without consequence. not that he won't allow it...he CAN'T allow it. difficult for finite minds to comprehend, mine included.
i'm learning it's never worth compromising. never. what appears to be worth compromising for is a facade. the consequence is always worse than perceived gain.
but this is a pharmaceutical message board, so i digress... :)
a number of things could have caused the delay. i give them credit for having said, 'we INTEND to file in the second qtr', though, instead of, 'we WILL file...'. on another note, perhaps they HAVE already filed, unbeknownst to us, and will inform all as the process unfolds...
"Rock Creek Pharmaceuticals has contracted with Quintiles for the preparation and submission of an IND package for our compound."
HAS contracted...it will happen.
when? you ask.
but soon is so relative.
i can't wait.
you'll have to.
your analogy is irrational. if you intend to marry a girl you are engaged with, and she leaves to marry another or she dies, that was a rational intention that was altered. filing an ind in the second qtr was also rational. it's called life. things change or get delayed. some runners did not finish the boston marathon after the explosion. they intended to finish, but something happened to cause the change. intentions must be reasonable and genuine to be meaningful.
i don't recall them ever saying there would be an announcement at the end of q2. i do remember they INTENDED to file an ind in the second quarter. the intent was there, and possibly still, and yet delays do occur...
there's undoubtedly a problem. but i would not initially go to the shareholders with this information were i in their position. collect ample factual data first. organize it. present it to those who can reprimand. then update shareholders on progress. it will happen in the right time.