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No such thing--the FDA can play Q&A until hell freezes over if they wish. However, if their questions have ceased and answered fulfilled, thirty days for an approval or declination.
Hmmmmmmm.....you may have lost me on that one???
I don't know about that.
But, fair enough.
GLTA
I understand that the BBSE is one of the few exchanges where a companies can be traded without authorization by the company. However, it has been seven months. The likelihood of BMSN not knowing they are on the exchange seems minimal.
It seems to me the mention of being on the BBSE may be cause for alarm by suggesting nefarious play is another attempt to scare the bejeezus out of investors thereby causing them to dump their shares.
Hinting that there is any reason to be concerned because they are on the BBSE is overkill, IMHO. Now, if they just popped up a week or two ago, that would be a different story. But, it has been seven months!
Why is this suddenly a concern? BMSN has been on the Berlin exchange for seven months. Why now, when the time for significant progress to surface is at hand, does their trading on that exchange cause alarm?
You said: "No PR about IND approval by next week IMO means they weren't approved for a second time."
And your point is???
They weren't denied either! Q&A have gone on for as much as several years with the FDA. Granted, this is generally when a highly addictive drug is being developed. But, it is not uncommon for Q&A to go on for several months at the IND stage.
We're not talking about what color to wallpaper the bedroom. This is the process by which a newly developed medical treatment is being tested on human beings. There ARE going to be questions. It IS going to take some time. And we ARE dealing with the FDA. Dealt with them lately?
---Thanks, ya'll. Before I am off, a pebble of wisdom...
Back in the day, when ole' Ben Franklin was part of an elite group of thinkers that sowed the seeds for the American Revolution which of course finally established our independence and paved the way for America to be what it is today, his brain was always thinking of ways to advance civilization. Whether it be by way of changing the postal system , the wood burning stove, bifocals and a many number of other things, he was always coming up with things that to this day change the way we function as humans. And boy have people made $$$ on these ideas/inventions. Did it matter to Franklin that many scoffed? That many accused him of wasting time? Of course not!
I could cite many more examples (such as Thomas Jefferson as I type this in my swivel chair) but since we will be celebrating our Independence tomorrow, ole Ben seemed apropos.
All that said---understand what you are invested in and HOLD STRONG. Our beloved BMSN and the great minds behind it are responsible for the same revolutionary thinking. Thinking that, when it is all said and done, will secure their places with an elite group of scientists that change the face of many treatments, FOREVER!
Happy 4th to all!
BMSN!!!!!!!!!!!!!!!!
Oh, I am sorry, does your response mean that you do not understand my post????
What some are failing to realize is that this is not just about BMSN. What this company now owns is part of a project that has been developed by one of the leading names in stem cell research--a scientist whose work has been accepted & touted by some of the most respected and renowned people in medicine. This is a joint venture that has been years in the making. Negotiations for utilizing the technology in various places around the world has been in the process for years.
It IS all going to come to fruition. When it does, people making a couple hundred bucks a day on flipping are going to be so very sorry.
BMSN
Seriously? Even with the o/s as it is? Would you expound upon that? Very interesting.
Perfect, thank you! Though I do hope you don't get arrested for indecent exposure or something akin to that before you have answered me! ---Just kidding, just kidding!
Seriously, thanks! Have a grand Independence Day celebration.
That was going to be my second answer.
Because, at least to me, he seems to have a pretty keen insight into how certain things effect the activity of these sub stocks. I have read through quite a number of his posts and think he has a fair idea about some of the questions I want to ask. Even if I don't agree with his ways.
I have asked similar questions to no particular person before that have gone unanswered. Maybe if I direct my question to him I will get answers.
That is why.
BMSN
---Hey 1-eye...
I am working on a thesis of sorts about my position in BMSN from a scientific standpoint to offer to someone who has mega interest in the stock. If I draw some parallels with other companies and incorporate that with what the prospects are within the pharma world, would you give me an honest opinion on long term pps possibility/probability? I don't have PM on here so would have to post it. I will probably give a basic synopsis tomorrow evening sometime.
Seriously? What kind of BS whacking is that? Does that pay lot rent or something?
Good grief!
Go ahead with ya bad self. I think my side of the scale will ultimately be filled with a much heftier bounty!
BMSN
I think those of us that understand the science and formalities involved in dealing with governmental bureaucracy own and hold--for the long run--very large quantities of this stock.
Not a single person on this board knows when trials will begin. We are at the mercy of PR's at this point. But, when they are free to practice this science that has been being perfected for decades, in human trials, even BP will start buying this and you'll be wishing you had stopped flipping!
JMHO.
BMSN!
Hi P0W (no one hate). Thanks! I found ENTB researching canine lymphoma last year. I have been hooked on BMSN since. I am a researcher and am in pharma so-to-speak (cannot divulge what I actually do or for whom I do it). And though I have had some misgivings about certain activities within the company history, I believe this to be a rock solid investment. As I have stated before, I have no crystal ball and there is a possibility that I could be way off. However, I don't think so and am very much invested in this company.
BMSN!
Yet, the bulk of your investments (or should I say verifiable interests) appear to be in penny stocks??? So, from an intellectual standpoint, your argument is moot since by your own words there is that 5% left standing and you have failed to provide any data to back your opinion.
Just saying.
Typically, opinions are based on an emotional interpretation of facts. Generally subjective. That being said, your opinion is based on ???????????
Your assertion is based on what? You have how much experience in the science? You have how much experience in the FDA process? You have data on actual and theoretical yields that would automatically preclude Hemaxellerate from being granted approval for human trials?
I'd like to know. Now, I don't have a crystal ball and cannot say for certain whether or not approval will be granted tomorrow or next week. But, I do know enough to say that you seriously need to back up the below pasted statement with some hard data 'cause it really smacks of major bashing BS.
------"the chance of approval is minimal"
Anyone familiar with my postings know that I am no stock guru. But, I do know the science and the intricacies involved in the FDA application/approval process. So, here is a question, and I invite all input by those savvy in the world of investing:
If (when) Hemaxellerate is approved for trials, since these are not blind trials, which means the information on the success and/or failure of the therapy can be known in as little as 30 days (depending on how the time frame is set up for blood evaluation), if success is showing almost immediately--at least in terms of trials--what can we expect the pps to move to in the short term with such news? Bearing in mind that if such is the case, there will most likely be a vigilant move to proceed with further applications for more treatments.
For anyone wondering there will be an acquisition (those listening to Sierra), nix that thought. Koos has no interest in being acquired--it is his aim to sell each patent/treatment to the highest bidder. Not the company itself. There is much more money in that. Much more.
So, anyone with any thoughts, please enlighten. That means even you ole' pirate!
BMSN
Thanks, Jay!
Actually, it is calendar days.
Thanks for the love, Jack!
BMSN
Thank you.
You said: "First of all, I hope you understand what approval rate looks like in the entire biotech/pharma space and the years of trials needed plus the $$ required to get approval even before a treatment can go to market."
I believe I was pretty clear about my understanding of the duration and $$$ required for trials. Particularly for smaller biotechs. Hence the mentioning of BP (that would be big Pharma) funding trials.
You said: "Secondly, do you know any company that received FDA approval with most of their trial subjects dead during P1 or P2? How will any company prove their treatment works if subjects do not live long enough to finish the study? Let's say for a minute that HemaXellerate showed positive response after 6 months in most of its subjects then in subsequent months, those subjects all passed. BMSN will meet its primary endpoint at 6 months of P1 but what would the secondary endpoint look like? Are they going to keep repeating P1 or do P1a, P1b and so on? How will BMSN ever prove their treatment works? Is it important that a treatment shows positive response or should it promote overall survival or good median survival? If treatment response is positive, why are patients dying and how do we eliminate positive response or death as an event that is or is not occurring randomly (chance) if we have a small study size like 10?"
I don't think you are understanding the concept of utilizing exogenous cells as a means of accelerating recovery. And until you do, you cannot understand how profoundly flawed your P1/P2 time issue argument is. Further to that, it is obvious that you do not understand how trials really work and what factors are considered from beginning to end. ----To quote the FDA: "Our action will depend on the characteristics of the adverse events, the frequency of the reports, the seriousness of the diseases or conditions for which the drug provides a benefit, the availability of alternative therapy, and the consequences of not treating the disease. Detection and limiting adverse reactions can be challenging. Weighing the impact of adverse drug reactions against the benefits of a particular product is multifaceted and complex, and involves scientific as well as public health issues.---
The science that HemaXellerate is derived from has been closely studied since the 1970's. And it is a treatment option that is long overdue in a world where 7.6 million people die of some form of cancer every year.
(Again, until you truly educate yourself on the above mentioned, I could go on until The Calling and it will do little, if any, good.)
You said: "I highly suggest you check with people in the medical/science field and get another opinion on this view. They will confirm and support my view without calling me names."
I AM in the field.
I can't bring myself to respond to the last bit of your message due to how ludicrous it is--you scoff and attempt to dissect, seemingly being an educated opponent, when in reality you know very little about any of it. I suggest you thoroughly research how pharma works and perhaps familiarize yourself with "data mining", how often BP infiltrates everywhere from hospitals to medical schools, and monetary persuasion. In this business, you only release what you absolutely have to. And oft times what is released is cloaked.
The biggest challenge Hema faces is that in an industry that is expected to reach 1.1 trillion in sales by next year, BP might have some problems with a treatment that may actually reduce the need for long term prescription drug needs. Depends on what price tag can be attached to the therapy (and believe you me, they are doing the math on this). We are talking about an industry whereby for every dollar spent on research, nineteen dollars is spent on promotions and advertising. No, am not kidding. That is the biggest challenge for HEMA. But let a BP determine that this treatment is in their best interest, and the sky is the limit.
Why are you on this board if there is no benefit to you?
BMSN
Even I, who knows the medical science but not the trading science all too well, know that aint even close to true.
Go BMSN!
I don't think that is what he is saying. In any case, what he is saying is absolutely nonsensical. Hence the responses.
But, before you exit, stage left, for a decade, please enlighten us with your infinite wisdom. Please explain to us why it is that although the need to explore the ways in which endothelial cells provide support, if not control, for hematopoietic processes has been emphasized throughout the scientific community for quite a number of years now, the FDA would say "naaaaaah"?----
Why, would the FDA NOT APPROVE trials for an intelligent cell therapy source? A therapy source that stands to assist in paving the way for revolutionary treatments for many inherited (and some acquired) diseases?----
Please, impart that wisdom!
Oh me, oh my! Was that love, Jack?
LOL. Thanks.
Yes, and Margaret Thatcher said there would "never be a woman prime minister in my time".
Hell is currently installing telephones.
Netflix might just be calling my name right about now.
I'll admit when I haven't a clue...what in the world is a "mule skinner"?
That's funny! I like that.
Let me see if I can do this like one of our favorite posters does...
The government will not fund the trials---there are no government grants in place. The company or a BP will fund. This is why trials are so lengthy for smaller companies THE COSTS ARE EXTREME.------- (insert a goofy smiley face here).
Hemaxellerate is a derivative---the possible offshoots from the source of Hemaxellerate is far reaching (now I will let you figure out what that means) and lands safely in the center of an 18 billion dollar market that is just a fraction of the overall market.------ (Insert goofy smiley face here, too).
Trials do NOT have to take place here in the U.S. (and whether or not Regen intends to conduct trials here, we still do not know for certain). Trials can easily be conducted in some place with a much higher % of AA patients. Someplace like, oh, I dunno, ASIA, where the private health care plans are very limited compared to that of the U.S. and where people line up for clinical trials like a crackhead at a methadone clinic (no offense to the Chinese).----- (insert yet another goofy smiley face here)
There are several large BP companies who have implemented major changes to their regenerative med divisions, working closely with international governments to conduct trials. Funding smaller biotech companies who have worked years to establish credibility in the circles who have shown reasonable amounts of productivity in this sector are ALWAYS in their best interest. It saves them lots of cash (even with multi hundred million dollar acquisitions though an acquisition is not on the table with Regen) and time funding trials when such trials conducted by a smaller biotech.------ (insert that goofy smiley face I have been mentioning again)
But, since you are a bio guru, you probably already knew all this, eh? Or not.
I STRONGLY encourage you to read and reread paragraph two of the above.
Not one that you can understand obviously.