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we don't know because the company can't yet get the FDA to allow it to see if it actually works. Maybe once the FDA grants REgen the green light to start clinical trials then we'll find out in ~18 months to two years based on when the trial starts.
Bobby, I have never posted for anyone to sell or buy. Please point me to any post where I have. My frustration, known to many on here, is the fact that the company is not telling us why they can't get a simple IND approved by the FDA.
Reposting snippets of the PR doesn't make a stock go up or give any credibility to the company. What does is FDA approval. So where is the approval?
It's sad that the company can't get past the easiest of all the phases and that's the IND.
How much more dilution is this going to cost the company? The only way Koos can pay her is with shares.
Great, now this incompetent company has another patent for a drug/procedure that won't get FDA approval either!
The three stooges could have done a better job getting FDA approval than these clowns.
Dr. Ichim was really that much of an idiot to state Regen has "products" with IND numbers! LOL. He's truly is a fool.
Ok, now I have to say Dr. Ichim is full of it with this very disingenuous quote. There are no functional products and none that are FDA approved to start clinical trials. He is a tool and falsely spinning what they have.
"Regen BioPharma has a track record of rapidly translating university originating intellectual property into products, as seen with granting of IND numbers for HemaXellerate and dCellVax. Additionally, the company has recruited top notch translational researchers such as Drs. Amit Patel, David White and David Suhy. I am very excited at the prospects of clinical implementation of the intellectual property that was assigned today," said Thomas Ichim, Ph.D
Right, no fda in europe. But you might want to familiarize yourself with what the EMA is.
What happens if Koos keels over in Tijuana after a night of Tequila and senoritas? Who takes over? Ichim?
Maybe but maybe not. The news of insider buying had no significant effect on the stock. But I hope we finally get something to get this moving up again.
Yeah but when will the FDA actually give it a GO? And that was published back on Nov 4th. OLD NEWS
You are now 3 for 179. NO news this week as you predicted! hmpf!
And not one of them involves Regen. Hopefully that will change soon.
Lol, because all the hand holding postive kumbaya posts over the last two years has done wonders for the stock price, right?
TrazyB, when is your spidey senses going to start working again so you can accurately predict news?
Only 455 shares traded so far? What is up with that?
I hope you are right for the 2nd time in two years. :)
Wait, what was the third, assuming we get good news this week that actually moves the stock up for once? The only one I know of is on your birthday where you finally guessed right.
Ah ok...I forgot. They are so far and few between ya know. HA!
Regardless, let's hope the fricken flood gates open this week with good to great news. I'd like to at least break even.
Hemaxellerate hit the FDA website ~6 hours ago when you do a google search for the last 24 hours. You won't actually see anything on HemaX but that the google search shows something was updated. What it means, who knows but maybe, just maybe, we'll finally get some positive news on it.
I didn't write that it was unsafe. As I have stated many times, the FDA isn't there to DENY INDs. Their role is let these go forward so that the clinical trials can accurately dictate if a drug or procedure works. My point was to soundly refute the incorrect assertion that HemaX and DCellVax are 100% safe. They have not been proven yet to be so and if they were as some on here are saying, the FDA would have easily approved the IND. We obviously know that hasn't happened because the IND submissions have been sent back to Regen due to them not being adequately complete. The FDA isn't going to deny on those grounds but will tell the company to answer or complete what they want before trials can start. Regen has shown to have a problems here. That's a fact.
Sorry Shlomo, Koos isn't kosher.
Serious dumping happening. 200K+ shares already.
That's the thing. Many of us had hope that the start of trading would mean we'd finally get some good news. Unfortunately we haven't seen that yet. I'll wait until the end of the year to see where things stand.
The funny thing is if the FDA doesn't approve the final 1/3 the other 2/3 are meaningless. You hopefully understand that. HEMA doesn't move forward to the clinics with just 2/3 approval. And this fixation of the 2/3rds approval as being some big accomplishment is just silly and shows a lack of understanding of the entire process.
The fallacy of your post collapses on the notion that what REGEN is doing is 100% safe. REGEN doesn't make that claim, at least not in humans. That's what P1 trials are designed for. And explain to me this. If what REGEN is doing is BEYOND SAFE as you claim, why then hasn't the FDA approved them yet? Wouldn't logic dictate that the FDA would have given the green light moons ago if they thought HemaX was safe? And didn't the FDA ask for more safety tests about 8 months back? Now, don't confuse what I am writing to mean I think the procedures are unsafe. It's just not yet proven in a human clinical trial that the procedure is safe. The FDAs pause is all due to safety or lack of clear evidence of it since the FDA wanted more tests done. So you might want to rethink your stance on the safety aspect of it.
I haven't sold the shares so I have made nothing. All I see is that the value of those shares continue to decline. I remember many telling us those shares would rise after the start of trading and that we'd all be going to the promised land. How did all that work out so far? We still wait for FDA approval and why do we still wait? Because of the miscues of management in filing those INDs.
What is the delay? What is REGEN doing to secure those approvals? We have no idea. Do your research and you'll find this is an abnormal path. Most companies get there INDs approved within 30 days of submission. The speculation of dreamers on here has always been wrong.
Who was it that said we'd be getting news this week? The week isn't done yet but still, we get the same bull and that's why so many are leery of those who post irrational exuberance.
We got the shares but they are proving to become more useless every day. That's not building shareholder value. We now have two INDS that no one knows what the hell is going on with them. We should have had an answer on DCellVax but all we got is an IND number which tells me the FDA has questions about it. So now two delayed INDs. Incompetence doesn't begin to explain this company.
What is with the huge dumping of shares? I thought this stock was tightly held? Yet someone is dumping. Might be telegraphing bad news coming. Another delay.
Or it could do what it has been doing for the better part of two years and head down ahead and behind news.
Many who have held onto the regen shares and BMS* have seen their so called shareholder value erode significantly. Selling their REGEN shares won't likely cover their losses in BMSN. If that's creating shareholder value then someone doesn't understand investing.
And just because Koos is your buddy doesn't make him a good CEO.
And as I and others recall, a picture was painted of how things would shake out. Those predictions were all wrong. Only a handful of people on here, including me, stated the opposite would happen and that we'd be lucky to see any growth. So far that's been the scenario. Many are guilty of message board malpractice on here.
Let's get those FDA approvals to actually prove the patents are worth something.
Remember the good ol days when people were smackin the 30's and 40s?
If I were perfect, I wouldn't have invested in this and the MoCo. I just didn't know how bad the company was managed.
I have actually written two emails over the last year. Never got a response. And you actually make my point. The fact that one would have to call to get clarification tells you how inept he is. The PRs are unclear about where they are in the process. All we know is that the FDA has cleared part of the IND but that there is one sticking point. The company has given no time frame what so ever as to when it expects FDA to finally approve HemaX. And there have been others that have had no success in getting any info from Koos. Just ask PG.
You are right, but it is also incredible that such doctors can't submit a proper IND for the FDA to approve! Why is that? why are us investors still waiting for it? Why has the company/Koos not explained what the exact hold up is?
One thing is for sure, he is shovelling a lot of what that horse he is on produces.
Gosh, i remember when i read, " under .004 was a gift." And then "under .003 was a gift" and then "under .002 was agift" etc etc. i am sure ill soon see someone write, " under .0005 is a gift.
Btw, when is that party in south beach going to take place? Anyone know? Is the motel stilll holding the reservations?