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Unfortunately, I find yesterday's PR one of the most discouraging we've had over the past year. It claims to be an update, but no update is given. All the info in yesterday's PR has been released before regarding what they "are working on". No time frame for anything.
In fact, maybe there was one update and it is this:
The Company also has an IND filed with the FDA on its HemaXellerate product for treating aplastic anemia (#15376). This product uses a patient's own stem cells to stimulate the production of blood. Currently FDA is reviewing protocols submitted by the Company for conducting an additional GLP safety study before clinical trials can begin.
Wwwhhhaatatttt???? This protocol was submitted Oct 6, 2014 after "extensive" back and forth with the FDA on previous telephonic exchanges. So after several submissions, conversations about protocol just for doing safety testing, here we are 3 months later with no further development on HemaX I which means if they ever get FDA approval for further safety studies, it will be another 3-6 months before they can submit those studies for the final clinical approval process to begin.
Put that timeframe 2.5-3 years after initial FDA submission of NDA and we will cannot anticipate any good news for clinical trials on any of the INDs in the next 6 months or more.
This is truly disheartening. I had hoped that Feb-March of this year we would get a PR that RGBP had submitted new data for safety of HemaX and 2015 would see breakthrough on initiation of clinical trials, but they haven't even started on the new safety data -uugghhh.
Sounds promising on paper, but this "rapid" development through IND has a non existent track record, no that's incorrect, it has a track record of non production thus far with Koos and RGBP.
Why is it that we have not heard of any development for months on the status of HemaXellerate I and DCellVax progress? Why, if there has been any progress going forward, why wouldn't they want to brag about it? Instead, we are 2 years removed from IND of HemaXellerate with nothing to show but a 2/3rds approval for clinical trials and no update for months whether there is any hope that it will ever take place, since the safe data was lacking and we have no update as to whether any further testing is being performed. DCellVax is over its projected submission for approval, so, in fact, why should we think this N... will be any different.
On the other hand, companies are breaking ground. Just came across JUNO which IPOed at 24 and is now over 50 within days on cell based cancer treatments. The more time passes without positive, concrete news on data and results, the less chance RGBP will ever make it.
Sorry, let's not bring up Ebola as a prospect when BMSN can't even get its tests approved for HemaX and dCellVax. How many months have passed and the last we heard on HemaXellerate was that they were in discussions on the right protocol for further safety tests.
We have no news as to whether those tests are even being conducted and now we should get excited about a patent purchase and talk of Ebola cure?
Let's be real.
And do you think the FDA is going to green light an IND just because they gave it a number?
The PR itself leads more to longer timeframe than shorter timeframe since it says it is going to be a process like HemaXellerate which an IND# was given to in early 2013. So then, why would anyone conclude that FDA approval for clinical trials of dCellVax are near?
Your post and language is out of line.
That is to be expected. The chances of first round submission approval should not be planned on, but a 50% drop without news means the "strong hands" behind the scenes don't appear very strong. Interesting that those previously telling us so many positive developments were about to come to light have also gone silent and absent.
I just hope the PR on ebola isn't a sign that both HemaX and dCellVax are basically DOA due to things we do not know. We haven't even gotten news on their submission for safety protocol testing proposal and whether it is even going to be done, let alone approval for HemaX.
I agree. This isn't "significant news" in the short term, especially given the "long term" development within the PR itself. But it may be a strategic PR to fill in the quiet period while waiting for the dCellVax IND review and hopefully we get a PR soon on HemaXellerate safety studies being underway.
Not on pins and needles for news, just hope the next 3-4 months bring significant FDA trial news so that 2015 is a breakout year.
If you go back to PRs relating to Feb 2013 IND for HemaXellerate, the PRs state that first they need FDA approval for clinical trials and then they would submit Orphan Drug status within 30 days of approval. Since aplastic-anemia has already been designated as a condition that qualifies for orphan drug status, filing and obtaining that status for HemaXellerate will only be a formality once it is approved to proceed with clinical trials.
Again, I am not saying they haven't. What I am asking is why this is not public knowledge if they have. That's something material that us investors should know about. Don't you think? And investor1 thinks it is or he knows it has been submitted? Two different things.
Possible PR next week or so: Dr. Patel joins Dr. Min in leading HemaXellerate Safety Trials Needed for FDA Clinical Trial Initiation. As follow up to our previous PR, Dr. Patel and Dr. Min will oversee the necessary safety trials in a GLP laboratory requested by the FDA to assure the safety of HemaXellerate....
I wouldn't be surprised. AIMO
A few thoughts:
First - for everyone expecting RGBP to skyrocket on every PR, get off this board and look at what is taking place in the overall market today.
When people act negatively to what should be seen as good news or encouraging news, one must ask, "What's up with that?"
Adding the Dr. who was the lead writer on the HemaXellerate peer reviewed paper to the Scientific Advisory Team can only be seen as a positive in conjunction with the safety trials and protocol needed for FDA approval of HemaXellerate. If Koos had hired someone without any experience (to save money or for whatever reason), that would be a terrible sign, but let's be positive that we now have the person who wrote the paper on HemaXellerate on the team preparing for its FDA approval of clinical trials, because trial approval is not the ultimate goal, it's the success of the trials themselves. Today's development is a positive and can only give hope that HemaXellerate is not dead in the water.
If you expect RGBP to be worthless, why waste your time on this board? This board should be used for exchange of facts and developments and the speculation associated, not for those not interested in the company's success' constant banter.
I did not expect today's PR, but I also see it along with previous comments of others as a good sign and necessary to build a record of transparency and TIMELY release of news.
Lets hope next week we get a PR on HemaX protocol finalization for safety tests and then we can wait for early Nov news on dCellVax IND response from FDA. If things keep moving and building on this pace, 2015 will be the year we hoped 2014 would be.
These are the PRs I would like to see come in a timely fashion:
- Announcement of final test protocol for HemaXellerate safety tests with timeline as to beginning, end, assessment before filing results with FDA as well as with whom the GLP tests will take place.
- FDA feedback on recent dCellVax IND with clarity as to issues and timeline for company response, if necessary (especially clarity as to whether or not further tests are needed and their expected timeframe)
- PR progress report on HemaX safety tests around mid-way point.
- PRs immediately upon any clinical trial approvals when they occur.
If results are positive, such PRs should create momentum and gather further interest. If news is negative, then only fair to communicate such with us investors.
Lack of trading in RGBP and BMSN is surprising. I can understand no one selling off, but lack of purchasing may mean bargain hunters are hoping to see an initial pull back from yesterday's gains. The fact that that isn't happening is positive and I expect this to climb as the day goes on.
Common opinion is that market reflect or price in anticipation of next 6 months, so we are finally entering a 6 month period (2014 4th Qtr and 2015 1st Qtr) where exciting and significant progress can be expected for company. With feet on ground, I see the real possibility of approval for both INDs within the next 4-6 months and the PRs released from now to then should help with more steady PPS increase and not just spikes and drops.
How many posts will it take for people to understand that HemaX has to perform more safety trials and submit that data before there is a chance for FDA approval of clinical trials?
dCellVax IND is now front and center. Look over recent PRs. dCellVax success in demonstrating effectiveness in human cells and all experimental studies submitted with IND. What is different and hopeful here is that this is after previous phone calls with FDA cell experts, so it could be that Koos feels that they have all that they need for approval. At least we hope so and that the human cell experiment might have been a result of the request of FDA. Also significant is the patent application for dCellVax based on what they have learned during this process which may mean this IND is much more solid than the initial IND for HemaX.
Price should hold here better because we now have 2 products nearing clinical trial approval and only 30 days with possibility of FDA approval for dCellVax. HemaX is still weeks to months away since more data is needed for IND.
Indeed, I was thinking what we might see is either Orphan approval or FDA approval in about two weeks. This will be followed up with the eventual response from the FDA regarding dCellVax.
One question I do have is, given that the pre-clinical trials were submitted to the FDA with the IND, would we get approval to proceed with clinical trials? In other words, are we just waiting for an IND number or an IND number and FDA approval to proceed with clinical trials for dCellVax?
Please consider the context surrounding all quotes.
The PR title was on the Experimental Protocol, not clinical trial protocol which we've been told is already approved. The only question remaining is proving the safety in the way the FDA wants.
Here are the 2 sentences after the phrase quoted which clarify the issue of the experimental protocol:
The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated.
"The most important aspect of any novel therapeutic utility in humans is safety of the experimental product. We are grateful for the cooperation of the FDA in working with our scientists in ensuring the appropriate preclinical experimentation is performed, so as to minimize risk to the patient population," said David Koos, President and CEO of Regen BioPharma.
If we leave our emotions and hopes to the side and just read the PR, it's pretty clear and twice repeats that RGBP has to conduct further safety experiments before clinical trials can be "initiated", i.e. approved. Pretty easy to understand.
Also pretty clear is they have been going back and forth with FDA cell experts on the phone as to what testing module (protocols) are best to confirm safe usage in humans (since the tests won't be on humans, there can be varying factors to discuss/debate) as well as what are you going to look for to determine "safe".
After RGBP/FDA discussions, RGBP submitted test protocols to the FDA for their review and approval before wasting another (3rd safety test) that might not satisfy the FDA. Therefore, we have a clear statement from the company at least on dialogue with FDA and submission of safety test protocols that they, RGBP, believe will result in data that will satisfy the FDA standards for safety indicators in humans, and the company is letting us know that is where things stand, since people were all over the place with the vagueness and I would say spin of the wording of the previous PR.
This PR is fairly straightforward if you've been following the developments of the past 2 years and I welcome it. Plus, I don't think they would have released the PR if they thought the FDA is going to shoot it down, so I expect another PR within 30 days saying that their safety protocol experiments have been approved and begun. Then they might give us a timeframe for the duration of those experiments before submission back to FDA.
If you read the PR at face value, it's not confusing.
My understanding as well. Preclinical safety trials in US do not include human patients, but the experimental testing has to be done in a way that indicates probable effectiveness as well as safety in humans.
As you will recall, BMSN conducted 2 experimental trials already on mice and submitted that data hoping for approval. From a previous PR about phone call with FDA cell experts, we learned that they are not satisfied with the data (we don't know why other than they were not done in a GLP lab). It seems reading between the lines that the FDA is looking for a specific test module that will give them the key data indicators they are looking for and while the previous BMSN HemaX experiments might have resulted in positive data results, the key data operators the FDA guys were looking for were not there and so they have been discussing the protocol for further safety experiments. BMSN submitted those yesterday and will need to wait up to 30 days (let's hope its 3 instead) for a thumbs up or down to go ahead with the PRE-CLINICAL safety experiments.
We expect these experiments will result in the data necessary for clinical trial approval. How long this will take is a guessing game since we don't know the protocol, but those saying this week or next for clinical trial approval are living a fairy tale or don't understand English.
Most likely we are talking weeks to several months for conclusive safety data.
AIMO
OTCDOC, if you mean .oo2s, yes. If you mean .o2 in less than a week, no I don't see it.
it has nothing to do with assuming anything, it is a simple objective observation that directives for running an appropriate safety trial comprising the type of data the FDA needs to see for future approval does not guarantee that the results of the tests will result in data positive.
"IS" initiated assuming it goes well which we are all assuming will be the case given the science.
But it's not a slam dunk. The FDA has not guaranteed final approval. They just have to get the testing protocol right so that it gives the FDA enough evidence to give the approval for clinical trials, something I hope we see in 1st Qtr 2015.
Exactly Popo. This was already inferred in the language of the Sept 10th PR that I commented on several times, but people don't want to seem to read and believe what the company itself says or doesn't say. More exciting to announce immediate trips to the moon that when they don't materialize, discourages others from investing.
I actually am pleased that company released a PR on this today which gives more transparency of the process and allows for investors to make better decisions. More communication, more chance for building trust and confidence that company will keep you informed. Something that's needed if this is to get beyond "flippers stage".
So we can still look and hope for dCellVax IND this month and an FDA response next month on that while HemaX looks to be delayed until 2015 to carry out the new safety experiments.
That's not what I'm gathering from this PR. It sounds to me like they just submitted an experimental protocol for a preclinical experiment to the FDA for approval. Once the FDA says that they think that protocol will be sufficient to prove the safety element that Regen has been trying to prove to the FDA's satisfaction Regen will have to perform those preclinical experiments and then submit that data.
So in essence, it sounds like they are trying to make sure these new experiments will answer the FDA's questions before attempting them.
Please read the PR - protocol is for experimental safety testing that needs to be done before FDA can review and approve the IND clinical trials.
Both drog68 and d5wr59mfi8's response are not reflective of the PR.
drog68 post# 144319
Post # of 144364
IMO, IND submission tomorrow or next Tuesday, followed by FDA news.
The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated.
"The most important aspect of any novel therapeutic utility in humans is safety of the experimental product. We are grateful for the cooperation of the FDA in working with our scientists in ensuring the appropriate preclinical experimentation is performed, so as to minimize risk to the patient population," said David Koos, President and CEO of Regen BioPharma.
With the much lower float of RGBP, I like its chances much better than BMSN to hold gains if/when approval news hits. The good thing now is that with yesterday's PR, we once again have an actual date to work off of, which also means we should expect another PR within Oct on IND filing and then 30 days for FDA response, which means those that are interested in purchasing shares need to be more watchful and selling shares carries higher risk.
I was extremely upset with the prior PR vagueness and then issuance of preferred voting shares, so I dumped all my BMSN within a few days and put it elsewhere. With yesterday PR and actual outlook of possible dCellVax success (I still think HemaX is delayed to 2015), I've taken the BMSN money and added more RGBP.
I agree. One thought that came to me regarding the dCellVax August IND projection miss: maybe, just maybe they discovered (Min) a better procedure/process when prepping or doing the initial dCellVax experiments which then led to the new patent application and new or further tests with the new protocol/procedure so instead of filing in August with original plans, they delayed the IND in order to incorporate this new discovery they are patenting which hopefully will make the delayed dCellVax IND even better.
Just speculation, but it might explain the delayed and vague PRs.
Canadian Trader's timeline for dCellVax progress should be stickied for all newcomer's to this board to have a great reference to read up on progress. No hype, no bash, just the facts. I great service.
Thanks CT.
With yesterday PR, I'm hoping dCellVax gets approval before HemaX.
Previous PR stated that they need more safety trials for HemaX which could take up to 4 months.
If Ichim and Koos have learned all that is needed for proper IND of dCellVax based on the HemaX IND difficulties, then I hope that yesterday's PR stating that they have all they need for dCellVax IND means it has the possibility of approval first time round, which means it will get priority over HemaX for first trial which is just fine with me. Should dCellVax help cure someone's cancer outright, we have high hopes of RGBP really gaining legs.
Agreed. We need HemaXellerate for the legitimacy it brings to instill confidence in serious investors. Assuming that it will reach clinical trials before dCellVax.
Since the latest PR states that dCellVax experiments have ended and they are beginning to write up IND, what is your estimate as to when they would be able to submit the IND to FDA given that they've already gone back and forth with FDA on protocol and manufacturing requirements for Hema which, being cell based, I would assume would be very similar requirements?
Appreciate the PR today. Unfortunate timing of release on a market sell-off day. Did add shares. Seems I was the only one buying as price went up and now has fallen back.
Why no momentum follow through I ask myself? Well, one reason may be that this good news had been assumed several months ago when PR was that dCellVax IND was expected to be submitted by end of August (which was a delay of original date). So while good news today on follow up of a new patent application which means they learned something important about dCellVax over the past few months, the IND still has to be written and if submitted by end of Oct, it's still a 2 month delay of latest PR projection. I added shares today bc I didn't think IND would come until 2015, so it's at least a couple months earlier and hopefully we get a timely PR when it is actually filed.
Unfortunately, if market continues to weaken, RGBP might not even hold these gains, but I'm hoping it will and can add as news slowly spreads. Too bad it doesn't treat ebola. ;-0
When you already control the majority of shares, why do you need "an insurance policy". That is, unless you plan on releasing more shares in the future which would eliminate your majority. So by issuing this insurance policy to himself, he can freely release more shares without losing control.
Did the same with BMSN and Big Pharma haven't knocked down his door, have they?
The Koos Game continues: http://biz.yahoo.com/e/140919/rgbp8-k.html
600,000 special shares with 10,000 votes per share. And to whom will these shares be issued? I imagine the board members. Who are the board members: David Koos. So that gives him 6,000,000,000, that's right 6 billion shares voting power. Well, our hopes of RGBP skyrocketing because of the small float may very well be changing rapidly in the near future as common shares will be issued to raise funds and at current pricing, that could mean hundreds of million of shares. Watch our for a PR stating that "the board" has authorized more shares within the next month.
Traz,
So you feel its good business to issue divvy shares to LT holders, then launch the new ticker symbol RGBP, (oh, I forgot, they didn't launch the new ticker symbol or even issue a PR about it going live to trade), with a delayed vague PR about how you have to do further tests for HemaXellerate (not mention pending patent app) without any timeframe or info for investors to hang on to or chew on, then a few days later issue a more important, good news PR about patent application for RGBP.
This is to be considered good policy and positive SOP for shareholders? Or, is it just good insider manipulation to reward the few and scam the rest?
Don't bother. It appears to me that NITE is all investors who trade through TDAmeritrade - at least that's where my buys/sells show up, so you are talking about probably a lot of the people who read the board.
That's just it, no timetable has been given. In previous email, only "clarification" was needed after back and forth with FDA. Now, 4 months later the next PR says that further safety tests are needed (it took 4 months to figure that out!???).
No time frame of call and no time frame for testing and latest financials showed no money spent on R&D in qtr. So I have finally had to ask myself, "Is this a real company?" With the work needed for the divvy payout, I thought it was. I now believe Koos thought they were going to get the IND approval for HemaXellerate I with previous submission and he was lining everything up for that. When the IND went sour, he left us in the dark and stalled for time, maybe allowing close associates to slowly sell some stock before the PR.
Now the PR doesn't give us any time frame to judge. He probably has to find a GLP lab, find funding and then go forward. Meanwhile, other companies are getting patents related to dedentric cells and the longer this drags on, the more chance big investors go elsewhere. For dCellVax, BMSN previous PR estimated testing to be 1 month for efficacy and FDA toxicology testing to last 4 months and then 1 month for submission. This was to happen first by June 2014, then postponed to August 2014, now we don't know, but my point is that safety testing for FDA IND was estimated to be 5 months from start to finish.
If this has to be redone for both Hema and dCellVax, then we are looking at first qtr of 2015 most likely.
The fact that PR was terribly vague - who would want that to be the first PR of a company's new trading ticker??? The fact that no dates and no specific good news was relayed tells me it is worse than expected and nothing is around the corner. Otherwise, you would put the best foot forward for a company's first PR, wouldn't you think?
AIMO
Ask yourselves, who will fund new safety experiments?
I hope Koos will not dilute RGBP to get cash to pay for GLP testing. It would seem to make sense that since he has a couple billion shares approved for BMSN and the divy has been paid out, that Koos would sell more BMSN shares to get money to fund the Hema tests. He doesn't have too significant a margin of shares in RGBP to keep the majority, so I would expect news between now and Dec regarding the release of more BMSN shares in order to fund the Hema tests.
I would not be surprised in this case to see BMSN drift lower over the next couple months.
No panic here. We waited for months for a PR that does not give confidence that anything is on it's way.
What is clear is that HemaXellerate needs more safety data procured from testing in a GLP lab. What is also clear is that despite having submitted the IND for HemaXellerate in Feb 2013 (count the months), only recently has BMSN clarified with FDA that that is still needed. If it took over a year and a half to determine this, all after BMSN had submitted the IND to FDA with at least 2 rounds of Q&A, then we can deduce that we are still months away.
If Koos is honest in saying the need for more safety tests are based on the cellular nature of the drug, then the same protocol will apply to dCellVax. It doesn't make sense to assume dCellVax tests were done in a GLP lab if HemaXellerate was not.
Ergo, we are months away from any news that can prop this stock up regarding the 2 drugs it has been pursuing and concentrating on over the past 2 years.
Panic, no, but look at the facts. For those who are only tying up free money and can wait, they can keep buying. For those of us who invested all the available cash we could free up expecting some return in 2014, that no longer seems to be an option.
Well, let's see. IND submission in Feb 2013 for HemaXellerate. Modified IND submitted in May 2014 after ongoing dialogue and Q&A back and forth with FDA over that time. 4 months later a PR that they are now happy to know from FDA that their safety tests need to be done in GLP (and from PR on dCellVax, FDA requested saftey tests take at least 4 months to complete). So unless they is some other manipulation going on, we can anticipate that no FDA approval for HemaXellerate is forthcoming in 2014 and best case scenario is now Jan/Feb 2015 at the soonest.
As for impending dCellVax IND, - don't think so. Most likely dCellVax to have to undergo same routine. With both most likely needing the safety tests redone, we are looking at 2 stocks that will languish from now until at least early 2015 with the next PR hoped for to be positive at that time.
Until then I expect only financial quarterly reports.
Bummer.
IMO
Today's RGBP PR makes my blood boil. No date of call, no time frame for extra safety trial, no info on how this will impact dCellVax IND. [But the reading between the lines is that because dCellVax is also a cell based drug, more safety trials in a GLP approved clinic will be necessary - so after a couple years of dealing with the FDA, Koos and Ichim and Suhy have finally found out that they didn't do the trials in a proper lab. Wow, after being president of Medistem and submitting and resubmitting modified INDs, we now find out that at some point Koos found out their saftey data isn't good enough and how they should do it. Hey, 2 years of back and forth and 4 months after submitting their recent IND in May, we find out. So much for the to the moon news. Hopefully they realize this affects dCellVax before too long.]
Nothing substantial in PR to help us know the future other than verifying what we should have been told weeks or months ago. Or even worse, they just talked to the FDA about what they need to do 5 months after resubmitting their modified IND on May 6th.
It takes 4 months to get an empty PR with no substantial info on what, how long or when their first major drug could be resubmitted to FDA for clinical trial approval.
I just sold 90% of my BMSN holdings at a huge loss this morning as I'm sick of this. Maybe buy back at .001
Holding on to the free divvy shares in case this eventually gets some kind of act together.
This is where I have been losing confidence. This was to be addressed in a timely fashion. We are over 4 months out from the date of this PR statement - 4 months without a drop of news - nada and the latest 10-Q showed no money spent on research. So what's going on? What is a timely fashion, a year, 5 years, 10 years. A drug which had a timeline of initiated clinical trials beginning a year ago has now disappeared - into silence - no clarity as to what the company is doing, what the problem was, whether or how it will be overcome. NADA.
Believe me, if there was a boatload of good news, we would have heard about it.
I fear I've been taken on an extended journey to no where.
This supports why safety issue will pass
"Given the HemaXellerate I(TM) product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member.
The more time passes in silence the greater chance the news will be bad when it comes.
I've been in since March 2013 and increased shares along the way with the official PRs giving timelines, with great anticipation. Now the timelines are all defunct and we sit in ignorant silence.
If positive ground breaking news were "around the corner", then a normal plan of action would be to issue some smaller PRs giving notice of the upcoming news in order to build increase, price and such in company and stock to enhance the release of positive news. The pattern we have when deadlines previously set by company pass in silence is that we will get rehashed generic news with bad and promise weeks to months later.
The fact RGBP, whom many said would open from $2.00 - $5.00 can now be bought for .30 (the company knows it's happening) and does not even comment on the stock symbol is not a healthy sign in my opinion.
Can anyone put together the facts we know and come up with a concrete positive reason for them?
Not worried about dilution, worried over stock chart trading the past week. The insiders know the scoop ahead of time and people they talk to buy/sell accordingly, often tipping the hat of a stock's upcoming direction on release of news.
Well, as more and more people talk of impending great news and the fact that RGBP is now a trading symbol, one would think we would be witnessing some accumulation and uptick in price of BMSN for sure on the positive speculation, but what we have seen on an increase of volume over the past week or so is a decline on heavier volume which really gives me a bad feeling.
If we get to end of September with continued silence, consider the silence a death knoll.
I agree. Has to be a new low for a company's stock to begin trading and the company doesn't even announce it. Especially when the company issued special dividend and was promising news before the end of August. No news on development, now no news for company's stock to trade.
No news is this case is not good news.
LetsRoll9696 makes some good points. The fact that RGBP is trading at pennies if "the perfect fire storm" is pending just doesn't make sense. The only people with shares to trade are those in the know and divy holders.
1. Those in the know might be selling if they know of bad news that neither Hema nor dCellVax are headed forward or they have encountered delays that will necessitate many more months and further dilution, otherwise, makes no sense for them to sell a new ticker symbol days away from "major news" that would have this trading above $1.00-$2.00 or more.
So today's developments without a positive PR immediately after close (and why wait till close for a new ticker) does not bode well.
IMO