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Seriously? So, Joe Blow mad scientist cooks up something in his lab and submits an application for trials to the FDA. And because in his application he doesn't indicate that there is a very good chance that the subjects will grow a foot out of their head, the FDA automatically approves the trials on his word? They just want him to work out the little details of how much of this fabulous new treatment he has concocted will be distributed?
OK, yup, I am game for that.
Yes, BMSN, please do!
On Fire...what are the purpose of trials? Human trials are conducted to test whether or not DOSAGE of a treatment is safe for humans. The first thing for them to establish is HOW MUCH of said medication or treatment is safe once they have PROVEN that ANY amount of it can be considered safe.
He was being a cheeky. Pay his comment no mind.
Porky, you are very welcome.
When all else fails, please read the links I have provided on the treatments, the men & women behind them and the challenges they have and still do face. As I have stated before, they are not digging for uranium. Nothing here is as cut and dry as some would have you believe.
Good luck to you!
On-Fire---the dosing IS the trial. There is no trial without "dosage" and vice versa.
Porky, this "delay" is a myth created by people who do not understand the process. And by people who may very well understand the process but wish to play on the fears of others.
There is no definitive time frame UNLESS everything is perfect during submission. NOTHING is ever perfect. Especially when you are new to the game. And although the scientists working with and for BMSN are very much seasoned in what they do, the company itself is new to FDA trials.
This "delay" is a myth. They are in a hurry up and wait, how high do you want me to jump? mode. Please understand that.
Absolutely untrue. Porky, I am in your corner most of the time. But, this time you are very much incorrect. Please do not encourage such erroneous and inflammatory postings as you have with this response.
Let me be clear: A clinical hold is imposed typically AFTER the FDA has provided approval and an issue has surfaced post this approval (i.e, through further investigation they find the applicant submitted false or misleading info, human subjects will be at certain risks not indicated in the application, subjects are being used that should be automatically disqualified for other risk factors, etc., etc.,). The application process has not reached the status as of yet (that we know of) that would subject it to a clinical hold.
The current state of the application is the process whereby the FDA is seeking answers that may or may not have been clarified during the initial submission. Perhaps they are seeking more info on who will actually be conducting the trials. Perhaps Koos omitted a minor detail such as something with mandatory exclusions. Perhaps the application lacked a signature. WE DO NOT KNOW! But, I DO KNOW that there has been absolutely nothing to indicate there has been a clinical hold on their request to proceed with clinical trials. NOTHING! NOTHING! NOTHING! On the contrary as a matter of fact if you look at the studies in toto.
Please stop assuming the worst because the best has not been placed before you. There is nothing easy about dealing with the FDA. When was the last time anyone had their tax return considered without inputting your income? It doesn't happen. We are talking about conducting human trials and working through the FDA. It can be a nightmare at times and it does take time!
BMSN!
Don't get me started on you again!
Though "backstage" news would be insider info or pre-PR leaks, formalities are NOT DELAYS!
Go BMSN.
Each PR costs $$$.
IMHO, presently there are a couple of monumental events being ironed out. If folks would look closely, they will see that there have been successful human trials directly related to the therapy presently being considered by the FDA for approval.
For all we know, Koos could be negotiating with a BP for trials funding for this while at the same time dotting i's and crossing t's for the next FDA submission. We just don't know. Understanding that when a BP spots a treatment that they want to add to their collection, they will happily fund the trials for said treatment. That leaves $$$ for Koos to pursue more treatments/sciences to generate more $$$ thereby ultimately lining the pockets of shareholders.
But, we will very soon.
Go BMSN.
I am sorry, Sabai, did you say something?
Until you have proven that you know ANYTHING about biotechs, pharma, trials, oversight, compliance, regulations, etc., etc., etc., and that your knowledge trumps my years of experience in the business not to mention my VAST knowledge (at least as it compares to yours) by way of my ability to comprehend the dynamics, your points are moot.
You are merely bottom feeding, looking to capitalize on perceived weaknesses. And that might be working for ya now. But long term, pretty sure your frenzy will end with you feeling a wee bit empty.
Go BMSN!
One last note---It is not uncommon for Big Pharma to fund trials for smaller companies. If a BP has a keen interest in a treatment, they will fund the trials. It is very cost effective for them to do so as the million or so required for typical trials is but a drop in the bucket for BP. And, it saves them a lot of headaches to write a check and have someone else do all the work. It happens regularly.
GO BMSN!
Not for Hem--it is multi-faceted with the possibility for several (or many) scions. Too complex. Someone will buy.
The amusement must be quite entertaining since you are back for more. Perhaps you'll be bemused when you can no longer obtain a piece of the pie because you were too busy choking on all your laughter.
My question for everyone with nothing but negatives to spew:
WHY ARE YOU HERE?
BMSN!
Thanks, Jack. I will try to follow-up later this morning on the various options for Hem/Hema.
GO BMSN!
siRNA patent license (I will get to the Hema later when I have a chance): Assuming all negotiations have been successful and judging by Koos's stated plan, they have been: (As of June 2012)
Oh, but note: Koos has no intention whatsoever to merge with a BP or be acquired. It is his plan to obtain then facilitate the necessaries required to perfect certain sciences/treatments, taking them into P1 or P2. Once success in human application is established during one or both of these trials, basically all of the hard work is done. That is when BP steps in to purchase. Depending on the treatment/science, there will be all out bidding wars. There can be an outright purchase for the patent by BP or there can be a similar negotiation as in the case for this particular technology between Regen & OHSU.
BMSN will pay OHSU (Oregon Health & Science University) a license issue payment of Thirty-five Thousand Dollars ($35,000) within 30 days after the Effective Date. Option fees may be credited towards this license fee.
BMSN will pay OHSU the following amounts within 30 days of Licensee or any Sublicensee achieving each of the following milestones:
$25,000 on the enrollment of the first patient in a Phase I clinical trial anywhere in the world for each Licensed Product.
$150,000) on the enrollment of the first patient in a Phase III clinical trial anywhere in the world for each Licensed Product.
$250,000 on the first regulatory approval anywhere in the world for each Licensed Product.
2% Of Net Sales for royalty payment outside the Least Developed Countries; which percentage may be reduced in half where the Licensed Product embodies solely the Know-How and not the Patent Rights.
1% Of Net Sales solely within any of the Least Developed Countries that exceed Costs.
For the first four years until the first Net Sale, BMSN will pay OHSU a license maintenance payment of $1,000 by each anniversary of the Effective Date. Beginning in year 5 until the first Net Sale, BMSN will pay OHSU a license maintenance payment of then $5,000 by each anniversary of the Effective Date.
Commencing on the first January 1 to occur after the first Net Sale, and for each year thereafter, BMSN will pay to OHSU minimum annual royalty of $10,000. OHSU will credit payment of minimum royalties received against any subsequent royalty payments made by BMSN, but only for the year in which the minimum annual royalty was received.
Technology Sublicensee Payments. BMSN will pay OHSU the percentage set forth below of all remuneration received from a Technology Sublicensee, whether in the form of money, equipment, property, equity, debt financing or any other cash or noncash consideration, other than sales generating royalty payments to OHSU. The Parties will negotiate in good faith to determine the fair market value of all noncash remuneration within 30 days of receipt, and BMSN will pay OHSU such amount by the end of such 30 day period.
30% in the 1st year.
25% in the 2nd year.
20% in the 3rd year.
15% in the 4th year and thereafter.
Reimbursement of Patent Costs. Within 30 days after the Effective Date, BMSN will pay OHSU the sum of $9,167.12, which represents Patent Costs incurred by OHSU as of April 30, 2012. BMSN will also reimburse OHSU for all Patent Costs occurring thereafter pursuant to Section.
BMSN will retain ALL commercial rights.
BMSN
You just gave me goosebumps and that is hard as hell to do!
Dang!!!!!!!!!!
TYVM.
Anyone familiar with (ERC) in Pt's With Critical Limb Ischemia? Or, have an association with IUPUI?
BMSN
TYVM! I am not seeing that--suppose I should log out and back in.
Thank you, very much.
It was an exciting day, wasn't it?!? It'll take me half the night to read all the messages. Based on the obvious excitement though, I pretty quickly deduced that Sabai & Hogg must be pissed! Tee, hee. JK.
BMSN!!!!!!!!!!!!
----Patient924257
Is it just my goofy system or does anyone else see the bid at 009?
Go BMSN!
This week should be very interesting.
Long & strong on CLSN!
In case anyone forgot to do their weekend reading or were not present for the tutorials, please, oh please, when all else fails, enlighten yourself. Then base your judgement and action(s) on the knowledge you possess. It--knowledge-- is, after all, and amazing thing!
Good night and week all...duty and my semi-absence calls this forthcoming week...
Let's make this easy. Well, easily accessible. Not necessarily easy reading.
When you finish pulling your hair out trying to wrap your head around exactly what it is that Thomas Ichim, et al have been doing for many a year, be sure to read on for a wee breakdown of the challenges stem cell research has faced just from an ethical standpoint.
Then mosey on over to the next link that will provide you many links to various state laws/regulations on fetal stem cell research (appears as though has been a while since an update but I assure you, you will be well educated by each link).
Then, when you're finished there, click the last link for a view of what the busy folk at wiki put together for us with respect to the SCREA.
But you'll have to go all the way back now to the origins of opposition to really understand what scientists have faced. Nothing is ever as cut and dry as you have attempted to make it seem.
When you've finished with the above, let's then discuss siRNA.
Happy reading!
http://www.ncbi.nlm.nih.gov/pubmed/?term=Thomas%20Ichim
http://www.cirm.ca.gov/about-stem-cells/myths-and-misconceptions-about-stem-cell-research
http://www.ncsl.org/issues-research/health/embryonic-and-fetal-research-laws.aspx
http://www.en.wikipedia.org/wiki/Stem_Cell_Research_Enhancement_Act
(There we go!)
It is my firm belief (as the old adage insists) that fortune--in all its aspects--favors the brave. As well as the unorthodox thinker. Although the latter might be considered subjective, this medicine and the minds that propel it, are indeed thinking outside the box. And how brave and earnest they have been. As with many of us.
So, though my crystal ball is on the fritz, my confidence has not faltered (regardless the obstacles)....
GO BMSN & Good luck to all!
Wow! I just lost my entire train of thought in my efforts to synchronize data and read this board simultaneously. Thank you!
I am sooo looking forward to seeing the hard work of the genius mind make monumental waves in the world of cellular medicine. And when they do, there are some of us that will be riding the wave with them. Well, sort of--the workings of my mind pale in comparison to the likes of Thomas Ichin, Wei-Ping Min & their teams. So, I can only hazard a guess of what it will feel like to see that stamp of approval. Still, I sure do try.
Good luck & fortune to all those that have faith. Whether their position is long or not quite so.
Good luck BMSN, ENTB & all of those going to bat!
BMSN!
Awwww.
BMSN!
I had to laugh. Koos is Germanic.
Since Koos has already indicated that there is the possibility of more Q&A (last PR), further Q&A is considered immaterial therefore disclosure in this case is not required.
If I am incorrect in the legalities of this, someone feel free to let me know. I do not mind at all being corrected.
BMSN!
Listen folks, NO NEWS does not mean denial NOR does it mean apprvoal. If there is another round of Q&A between BMSN and the FDA, Koos is not obligated to disclose this. There are disclosure exceptions to the rule and having no definitive, as in this case, is one of them.
Further, as I have already indicated in previous postings, the third round of Q&A may very well already be in progress. The final call by the FDA may be anxiously awaited by BMSN. Or, the FDA could have issued the decision on the 3rd (not likely being the eve of the holiday and they all bug out early, doing hardly any work before that. Not, the rule but is pretty commonplace). If not, perhaps tomorrow. Perhaps not. Ya'll can speculate as much as you want. Truth is, we just don't know. Simple as that. Although, when taking the PR history into consideration, we should hear something this week.
I am banking on positive news.
Some fact & JMHO---GLTA!
GO BMSN & ENTB
Can you list one thing that negates the probability of approval?
BMSN
LOL, J. They have insisted similar!
Thank you, very much. Looking forward to seeing the hard work from all involved come to fruition.
BMSN!
As always, thanks for the love, Jack.
Very welcome.
My pleasure.
Thank you.
I tried, in vain, for some time to post the previous message with functioning links. I do not know why I had such trouble. So, sorry about that, folks.
BMSN!!!
Let's make this easy. Well, easily accessible. Not necessarily easy reading.
When you finish pulling your hair out trying to wrap your head around exactly what it is that Thomas Ichim, et al have been doing for many a year, be sure to read on for a wee breakdown of the challenges stem cell research has faced just from an ethical standpoint.
Then mosey on over to the next link that will provide you many links to various state laws/regulations on fetal stem cell research (appears as those has been a while since an update but I assure you you will be well educated by each link).
Then, when you're finished there, click the last link for a view of what the busy folk at wiki put together for us with respect to the SCREA.
But you'll have to go all the way back now to the origins of opposition to really understand what scientists have faced. Nothing is ever as cut and dry as you have attempted to make it seem.
When you've finished with the above, let's then discuss siRNA.
Happy reading!
http://www.ncbi.nlm.nih.gov/pubmed/?term=Thomas%20Ichim
http://www.cirm.ca.gov/about-stem-cells/myths-and-misconceptions-about-stem-cell-research
http://www.ncsl.org/issues-research/health/embryonic-and-fetal-research-laws.aspx
http://www.en.wikipedia.org/wiki/Stem_Cell_Research_Enhancement_Act
(There we go!)
Love it!
So, before I list a vast number of publications and accolades for Thomas Ichim (all of which are directly related to and/or affiliated with and/or published by the most renowned establishments within the medical community. Ahem, I mean medical world), please let us know, how much knowledge do you have in stem cell treatment/research? The area of study that has been Thomas Ichim's primary focus. From its inception to its original political and social opposition to its quieting (legal suppression) to its semi-recent resurgence, how much do you really know?
Before you start accusing a genius mind of being a scam artist (essentially that is what you have done) as you bang on your chest about your "dd", know what you are talking about. Your recent dissemination of erroneous information coupled with assertions that Thomas Ichim is not who and what he is being represented as is pretty bold and dangerous.
Now, perhaps you should really] familiarize yourself with the science of stem cell treatment, Thomas Ichim's work, his affiliations, etc., etc., then come back with a retraction and an apology to all of the people you may have just scared the bejeezus out of with your chicanery!?!