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Are we about to get Sept and yearly financials?
Yahoo finance yesterday posted a link to a chart for financials only through June 2015. I didn't see any new SEC filings, so wondering what's up. We should be getting an annual financial report soon one would hope, most likely before the release of FDA news one would think.
Nice to see VNDM off the sell.
No volume yet to confirm any FDA news approaching. Before FDA news I would suspect we easily have a day of over 300,000 shares trading.
Hiring of Dorsee Company another sign hopefully that this time RGBP really does expect not only HemaX approval, but moving forward other INDs along with introducing new IND on NR2F6 research.
IF this is true, 2016 will be encouraging, but the sign I'm looking for is company selling sales above .15 to raise funds, not at .05.
One can only hope that with all the new SAB members this year, and those added within the last few months, that it is a true sign that RGBP is nearing being able to either move current INDs forward or ready to submit new INDs with most development already in place.
Or we can hope that it is an indicator that RGBP has enough in lab data to present to these new SAB members for them to go out and solicit established partnerships to co-develop new INDs so that RGBP won't be continually selling off shares for .025-.05 each.
At this point, if I could sell all my shares at $1, I'd be happy to get out and move on.
Today's 8K insult:
dmort545, can you post where they said actual clinical trials would take place at the John Wayne Cancer Institute. As I recall, Kesari, who is both at John Wayne Cancer Institute and another national cancer research department will be conducting pre-clinical tests and development which is great and very positive in the long term, but I don't recall mention of actual clinical trials to take place.
Thanks,
To expect RGBP at this point to run to $15 on FDA approval of clinical trials is fantasy in my opinion.
If the FDA approval mentioned was outright FDA approval of the drug itself and not just clinical trials, then we could speculate on such a reaction to the stock PPS. But to say RGBP is going to run to 15 from .15 on FDA approval of clinical trials is pure fantasy land and no one else with any credibility should be supporting such a claim. Many small cap companies with products in later stages of development trade under $2.
If RGBP runs to even $1 on FDA approval of HemaX clinical trials I'll be happy and then if it runs to $2 on Orphan Status approval which is to follow, that would be very good. If that is accompanied by other significant developments, it might push higher, but let's not get caught up in $15 value with over 100 million shares issued.
Please. AIMO
NEW4THIS, while I respect all the DD and searching of articles you provide, let's not expect too much from SAB members. As the letters of agreement clearly state, the 100,000 preferred shares are in return for them hopefully calling in once a month to a conference call.
They are not there to write INDs and anything else, though they might give advice. They are probably there more for the hope that as RGBP develops products, these SAB will help spread the word and acquire both collaborators and investors through their own networking.
How many SAB members does RGBP have now and how many does it really need. RGBP is paying dearly for monthly conference calls, but we don't hear anything from the likes of David White anymore do we.
I'm all for SAB members and name recognition, but unless a further development agreement surfaces (as in the case with Dr. Kesari to do research), don't expect much from the SAB members as to hands on work.
Yes, you did it wrong. Take the money and divide by the shares, not the other way around in order to get Price / share. So $33,333 divided by 666,666 shares is .0499 cents per share. Once again, this company shows that it is only interested in giving a few exclusive partners immediate profits of 300% while diluting and undermining the long term shareholders.
There is not incentive or impetous for the stock price to even need to rise when you consistently hand out shares far below even the lows of the stock price itself over the past year.
These deals are the most discouraging aspect of Koos and company and show that Koos is not changing his ways. Bad for us and bad for the future.
This prediction is more preposterous than the perpetual doom and gloom provided by the same source. KBIO ran not on any approval, but because of a buyout of a certain investor who then created a pump and dump campaign.
If the FDA approval mentioned was outright FDA approval of the drug itself and not just clinical trials, then we could speculate on such a reaction to the stock PPS. But to say RGBP is going to run to 15 from .15 on FDA approval of clinical trials is pure fantasy land and no one else with any credibility should be supporting such a claim. Many small cap companies with products in later stages of development trade under $2.
If RGBP runs to even $1 on FDA approval of HemaX clinical trials I'll be happy and then if it runs to $2 on Orphan Status approval which is to follow, that would be very good. If that is accompanied by other significant developments, it might push higher, but let's not get caught up in $15 value with over 100 million shares issued.
Please. AIMO
At this point, with no urgent expectation of other news needed, it would make sense to wait for FDA HemaX approval and then shortly after that to unroll any other positive developments on the back of FDA approval of HemaXellerate to maximize investor interest and PPS.
If all that can happen in December, would be a very nice lead into the new year and some investment positioning by larger fish I would hope.
At this point the note holders would be stupid to unload until after FDA news (assuming it will be positive). Of course, since they got their shares at .028/share, they might sell some shares to assure their return, but the bulk of shares will be unloaded once FDA approves HemaX.
I would not anticipate a legitimate financial partner until after FDA approval. Given the history and timeframe on HemaXellerate which Canadian Trader updated and posted again today (thanks CT!), I do not see anyone committing big money unless FDA approves.
Cantor & Fitzgerald the main blocker at the moment. If CANT caters to international markets and traders, may be the terrorist attacks have truly shaken confidence in the future of the markets in Europe and people are selling anticipating markets dropping. CANT has another 20K shares at ask at .135, but bid has moved up to .13 with over 30K shares with CDEL.
I certainly hope we can expect the bid to move up as time ticks away and FDA approval is anticipated.
I don't recall nearly everyone claiming RGBP was holding back the news, but nearly everyone was expecting FDA approval news because yes, we thought the Sept 25th CRL audited report data would be "forwarded" or compiled and submitted in proper form to the FDA within a couple weeks or so, leaving 30 days after that for news.
No, we didn't expect it to take until Nov 17th to submit the data. But our expectations now remain the same, i.e. that we will hear FDA news within 30 days of data being submitted, so yes, I do expect FDA news, good or bad, but certainly expecting good based on data and PRs released and prior FDA approval for manufacturing and clinical protocol already in place. We have been told the safety data was the last hurdle and we've been told the safety data shows no toxicology concerns, so yes, it is reasonable to expect FDA approval at this point.
Well, I guess CANT can't wait as CANT just unloaded over 30,000 shares at .131
Of course the PR misspelling HemaXellerate as "HemXellerate" twice in the first paragraph of the PR doesn't exactly instill confidence in investors, but now that we should be on 30 day countdown, why this trades how it does after news is always surprising.
For those without Level II, we currently have 20,000 on bid at .126/.1261 and 10,000 on ask at .154 with VNDM holding at .16
Now that we have the official news of FDA submission, it will be very interesting to see how this trades over the course of the next month. Will interest pick back up? Has the drop in PPS and lack of trading been due to those posting doom and gloom that FDA had rejected (erroneous) RGBP's response?
We now know that we should have FDA news by mid December and if there is a Santa Claus rally in the market, I hope we will all receive a very nice present for Christmas.
Wouldn't that be nice?
Very true that most of us are not aware clearly of the entire process, but there were some that claimed to be part of the industry who also claimed a much quicker turn around for everything, so, I must admit, finding out they just submitted the final FDA response is disappointing.
That said, it is also good to know that the lack of FDA news was not a sign of lack of FDA approval, but instead, no opportunity for FDA to approve since they hadn't heard from RGBP.
Note that the PR also said they included data on the clinical trials, so that might mean that there has been some changes in the proposed clinical trial procedures or location. I see this as an optimistic sign that with RGBP's new relationships and new SAB members, that they may have a better location and working relationship to do the clinical trial than what they had when they submitted the IND. I think the clinical trial arrangements and protocol with GLP might be more reason for the delay than the prep of the CRL data.
Just a guess.
Just incredible on how interest/buying has dried up here.
Not even $2,000 worth of stock purchased/traded today. Avg down all while we are near or past the expected time of what we have been led to believe will be significant positive news.
Just not right.
But all I can do is wait. Shares at this price aren't worth much to try to rebuild what has been lost. I sure hope you are right Laddyman and that we get BIG news next week.
Not saying good or bad on shares, just that I hope they were issued and used wisely as their value compared to ours should at least be $600,000 or more and since the payroll is not even $100,000/month, I want to see the cash/application.
If we find out another 5M shares were issued to cover a debt or loan of $50K, then we are in trouble.
Thanks for checking on O/S. But 118M shares outstanding is 4 million more than a short time ago, so I wonder to whom the 4 million are going? Severance package, new president, sold to 'angel investor'. At market share price of late, that's about $600,000.00 worth of shares issued.
Will be important to see where they went. Should have a 10-Q coming up soon.
Hope this is just runner up news to FDA news on HemaX approval next week.
Several interesting things in this PR.
1. Preclinical trial to be at John Wayne Cancer Institute and not the UC Davies Cancer treatment center. Don't know the reason exactly, but interesting to note that the John Wayne Cancer Institute focuses on various types of cancer and cancer alone, with some FDA approved immuno-therapy treatments already in place.
2. As others pointed out, Landers is quoted as President in this PR even though his "presidency" wasn't to begin until Nov 15th officially. The PR of his replacing Ichim only mentioned his taking on the chief scientist office on 10/31.
3. The fact that pre-clinical studies are to take place outside of RGBP and under direct management of Kesari. I see this connected to T. Ichim's health issues, but also as a positive for the company in a) being able to progress the studies more rapidly as well as b) most likely in an atmosphere of GLP. I think the more associations RGBP has with established and reputable organizations for its studies, the better chance of success and potential to attract larger pharma entities with its developments.
4. While C. Ichim is not mentioned, she has previously been mentioned as providing the abstracts and presentations surrounding NR2F6 research. But her research has been focused on leukemia (hope that's not associated with T. Ichim's health issues). So the fact that this usage of NR2F6 is mentioned as a possible new IND for a variety of cancers means that either her research lead to a more general discovery of how NR2F6 works or we will have more than one NR2F6 IND potentially in the future.
The fact that this news is good and shows good progress and relationships for the company, the total lack of trading volume is a surprise. I guess this confirms that without the anticipated HemaX FDA approval, this might not go anywhere for a long time. We need HemaX approval.
You'll have to look at those companies to track his activity there.
He was an employee of RGBP and Chief Scientific Research officer, so that is all RGBP is going to address in its PR. What his status is with other companies, they will need to release a PR on.
If he was a SAB member that only meets on a conference call once every 3 months, it may be that he will stay on if his health allows him (as his new contract with RGBP indicates) to do work on a less intense and frequent basis.
A conf call every month or so is not a major commitment.
Another interesting note. Yesterday's PR was 4 business days after what would be a material negative event it seems and therefore according to what others have said must be transmitted to shareholders. The fact that we haven't had a PR on HemaX would therefore hopefully indicate that no negative material event has occurred relating to the HemaX IND.
Several factors lead me to believe this was not an anticipated event:
1. The fact they hired a new President less than a month ago to begin Nov 15th, but had to change that hiring to Oct 31st upon resignation of T. Ichim
2. The fact the T. Ichim was recently announced as SAB I believe to another bio tech company
3. T. Ichim had a 3 year contract with RGBP with incentive shares
My guess is that T. Ichim was stretching himself too thin (Others have pointed out that his name appears associated with a variety of companies) and that he may have had a heart attack or mild stroke and is in a situation where doctors have told him unequivocally that he needs to rest/slow down and cannot continue daily work for a while.
I believe this was sudden and that is why contracts had to been altered to cover his resignation with a new contract for Landers. I don't think this has anything to do with C. Ichim who I believe has been leading the NR2F6 research.
Certainly, this is an unexpected and sad event for the company in some ways, but I do not believe it is a catastrophic event and the fact that T. Ichim is not severing ties with the company, but is on contractual pay means that as his health allows, he will continue to help forward the research.
I don't see any evidence that this is anything other than a sudden health event that is putting him on rest for the time being.
AIMO
It's already been a 2.5 year wait from the IND of HemaX. If, after telling us the safety data is all that is needed for FDA approval and telling us the audited data is in on Sept 26th, RGBP withholds information and there is no PR regarding the status of HemaX IND past 2 months from when the data is in, RGBP risks losing whatever remaining trust/hope of transparency from existing shareholders and the lack of sharing information along with past delays and failures will not bode well to gain significant and well grounded financial investors.
If we don't get news before end of November on HemaX, I'll be ready to give up on RGBP as a company even though I still think the Ichims have good science and work ethic.
Schuller, what about all the "unregistered" shares that were handed out as part of the "loans" converted to shares and/or unregistered shares to those in lieu of services and milestones? Since they are company shares and they are not registered, can't they be sold freely when their time-restrictions are up? There are plenty of those out there.
Don't see much use posting until we get further news. Waiting game to find out what the company has been up to and whether or not our hopes for HemaXellerate FDA approval and clinical trials comes to fruition sooner rather than later.
Addios until further news.
Thanks pretty funny.
I don't think companies want to post news during the last few days of a month, so expecting big news between 25th and 31st of any month is rare.
New money gets invested first week of month and first week of November should also be release of financials through September, which I think is fiscal year end for RGBP. Possibility that FDA news is released after financials since financials will most likely show cash very low with employee salaries and CRL experiments eating up most cash.
Logical that FDA approval news would come after followed by some type of cash raising plan to fund clinical trials. With new president not official until Nov 15th, don't expect news on funds to come until Dec or after.
End of month, we don't know if the cash burn has forced RGBP to sell more shares at end of each month in order to pay employees. Should have clearer view with next financials.
So, as a full time employee of RGBP (or is he) and director of RGBP development, why is T. Ichim listed here as part of Batu Biologics along with a lot of other Batu people?
This is a recent abstract and T. Ichim, as others have noted, seems to appear with many other firms. Rather disconcerting. Who is leading the charge for RGBP? Writing these papers takes time, so is HemaXellerate development waiting for T. Ichim to finish other papers? This link doesn't give me a good feeling at all, having the same names as RGBP SAB members doing so many things for multiple companies.
Laddyman, I'm not qualified to comment on 30 day approval if nothing said. I do recall reading that along the way when an IND is submitted, but not sure if it applies when IND is submitted, then FDA responds with questions and qualifications and further data needed.
Does 30 day no answer approval apply each time a company responds to FDA questions or new data requests? I don't know.
Does this mean he can issue up to 800,000,000 Preferred A shares or is the "aggregate"total the combination of 500,000,000 common shares and the 300,000,000 preferred A shares?
The other factor I guess is that while the new president was hired to gather non diluting funds, that won't stop Koos from continuing to raise funds through additional shares to whomever he pleases.
Can't say this 8-K instills confidence for the future. We started in RGBP thinking high PPS because we began with 50M shares. Now we are up to a possible 800,000,000 or 1.3B depending on what this means. And why raise the possible number of shares now when good news is hopefully imminent unless you intend to need and use them shortly. If this 8K indicates Koos is ready to raise funds through issuing 1.3 B shares, then we might not see the PPS rise above .50
This is water on the fire unless someone else can give an encouraging reason of why this 8K needed to be released now.
Sage, we could see a run any day, but getting FDA approval to begin a Phase I trial I don't see as propelling this to $5. I would welcome a sprint to $1.
I would not expect a run to $5 until clinical trials have positive results. Speculation alone without pipeline product trials won't propel this to $5 in my opinion.
Now if other news comes out about partnership developments with established companies etc, that could make for such a run.
Sorry. My post wasn't an attack on you or your post, but a reflection of what I think we should/shouldn't anticipate. My reference to Pfizer was not directed at you personally, but just part of what I anticipate as opposed to what others have posted from time to time on the board (that with every slightly good news, the claims of buyout and the like arise).
Not overly frustrated at all. In fact, at this point I don't even expect FDA PR news until we get nearer to Nov 15th, the start date of the new President and I don't think the new Pres. is going to walk into his job position with funds in hand, so at this point, we might have to wait realistically until Jan/Feb 2016 for funding of HemaX clinical trials to even be in place.
In light of that fact, RGBP might not be in any hurry to release news of FDA approval, even if it has occurred.
We are in the waiting game, but with greater possibility that significant good news will be released, but still a matter of time.
LaddyMan,
I don't think silence can be seen for something bigger. Correct that it should be that news of CRL report is not negative, but from PR, that seems already verified.
Regarding imminent news, we await news on HemaXellerate and FDA review. Biggest news there is approval and then I would expect Orphan Drug Status within 30 Days of approval PR for clinicals.
Next issue we will be waiting for is news on how clinical trials will be funded and when they are to begin. Way back in the beginning, there was a hospital and doctor named who would oversee clinical trials. Very possible that those conditions might have changed...
Don't think the wait and silence can tell us anything about these 2 scenarios. Our biggest hope would be HemaX FDA approval, ODS and then word on some type of funding/partnership acquired that pays for trials without heavy dilution. This to me is the brightest we should be hoping for.
Projections of being bought immediately by Pfizer or someone similar, to me is just fantasy. Get a couple cell drugs through phase II with positive results and then we can speculate on the big buyout. Now we need FDA approval and $$$.
And I'm beginning to wonder if we might not get news until well into November based on the new pres hiring to begin Nov 15th. Since new pres job description is to raise funds without dilution, do you think Koos will hold off on FDA news until President takes his position?
Likewise. Been painfully long in coming. Just hope it really comes.
Well, we've got CRL study data on Sep 25th; we were told the results were positive with no adverse effects; FDA is supposed to respond within 30 days and CRL can submit data electronically to FDA, we also have a PR that RGBP is hiring a new president whose job is to secure funds in a way that will not dilute the company (while the company promises up to 21 million preferred Series A shares in return), so unless it takes more than a week to prepare the data further to submit to FDA, one would think we would have FDA news within the next week, 2 weeks at the most.
Back in April I anticipated Sep-Oct for FDA approval of HemaX based on my estimates for the time the CRL study would take. I still think we should have news by end of October given that 2/3rds of IND was already approved per company statements.
Let's hope.
Sure is quiet around here. Quiet day of few comments and fewer trades.