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My sentiments exactly, BenK. We need to hope the almighty U.S. reviewers have the ability to compartmentalize and not allow potential adverse personal opinions affect the outcome of their decision on AS. Hey MO....is that articulate enough for you?
Given your relentless support of the previous administration, I am not at all surprised by your reply. Esposito has upgraded every avenue, and we're not dealing with Canada here. We're dealing with the U.S. The difference between Canada and the U.S. on the cannabis issue is huge. I stand by my concern. It was unprofessional and ill timed.
My two cents takes a different angle. Everyone has a right to work, including Doc Shannon. Whether we like it or not, recreational marijuana use is approved in only eight states, and medicinal usage is approved in only 18 states. There remains huge pockets of resistance in the U.S. among lawmakers, judges, and bureaucrats. The timing of Doc Shannon's announcement is most unfortunate, in my opinion. Here we are within a couple of weeks of, potentially, the 2nd most important decision in the history of Medizone, and a statement comes out that Medizone's Chief Medical Officer is working in the still highly controversial marijuana industry. I am aware of the nature of the work, have no problem with it, and wish his family the best. The announcement, however, could have been tabled until a more opportune time.
So......what happens to the "less healthy" patient, who might be less healthy specifically due to lupus nephritis, in the Phase 3 test? Does this person not have an opportunity to participate in the test? Is this test going to summarize efficacy % in patients with different levels of the affliction?.......just trying to think like an FDA reviewer. Is the current Phase 3 test protocol difficult enough? Any takers?
Let's try it again with a more seasoned management team at Medizone and a more seasoned team than C3.
Yesterday DE proved to us that, between 2008 and 2016, not much was going on at the corporate level except for Shannon and Zoutman continuing to develop the science. No one wanted to believe that there was so little going on. Well, now we know.....all of us know.....and DE is continuing to assess and address the landscape to create opportunities in every area possible. It sounds like we're starting from scratch because that's exactly what we're doing. It's a rotten shame, but it's still a case of better late than never. I think we were a lot closer to "never" two years ago than any of us thought we were.
What wasn't?
This is the beginning of the global awareness program that never was. It's going to take some time. We have been used to every meaningful press release being relegated and confined to the website and/or Yahoo. DE promised better communication at the shareholder meeting. It looks like we are starting to get it.
You can see whatever you wish to see, but no one will exercise a warrant when the stock can be bought for pennies on the dollar compared to the exercise price of the warrant.
It's normal for a stock to give up 50% of a quick run-up like Aurinia had.....especially when the news dries up for a while. It sounds like you're more of a trader than one looking for the long haul. Psychologically speaking, it's easier to sell than to pick the point to re-enter. If we go a couple of months without any news, then re-entry points could be considerably lower. This stock might turn out to be a great learning experience for shareholders who haven't been in the market much during their lives. Best wishes to all.
You don't get it yet, BR. You're probably a lot younger than I and have not been involved with the markets for 35 years. Again,low-priced stocks thrive on positive news. When that news evaporates for longer periods of time, the stock prices erode. That phenomenon is not specific to a particular industry but has been present in the bio-pharma industry for a few decades. Try to relax and have some patience. We're all going to need it.
Show us the math. The next two warrant expirations are 5-23-18. Where is the incentive to exercise?
No one will exercise a warrant if stock can be bought cheaper in the open market.
Just history, John, and nothing specific to Aurinia. The Feds have been known to change their minds mid-way through a few test protocols in the past. A company could be having great success in the middle of a test, and the Feds tell it to stop what's it doing and bring it to them. Then they find a way to shoot it out of the water. That's all. I don't want any bureaucrat upsetting this applecart after protocols were, originally, negotiated in good faith.
Whether this video is current or four years old, it needs to be removed. A former employee is touting a product where a claim is made that the FDA has not given Medizone permission to make. If it is from 2013.......sheesh........it had all of 33 hits.......nice marketing job!
What we are witnessing is the beginning of a two year process. News may not be prevalent, and there could be some investor concern pertaining to the difficulty of the P3 test compared to the P2 test (lack of trust in historical FDA guidance). Patience is going to be needed.
Shareholder meetings of any kind, that actually answer shareholder questions, will soothe our hands from the involuntary wringing that has afflicted them. Major upgrades to the Board are upon us with, hopefully, more on the way. Esposito, unfortunately, has to deal with a few unresolved issues from Medizone's past (510k, etc.) before he can move the company forward. The global awareness project, however, is emerging, and I am excited to learn what Innovasource has accomplished during its first quarter.
Biotech has become a stock picker's universe instead of an industry wide advance.....that's for sure. Some shareholders bought this stock between $1 and 2$ just a few short months ago. Now even though many of these shareholders planned to stay in for the "long haul", the downside volatility has a % of them thinking about protecting profits instead. This is a normal series of events in biotech land. So if the P3 enrollment is strong and the testing is positive, other upside opportunities will present themselves. Human nature tells us that, after such an unusually steep rise in the stock price off a P2 test, some shareholders are going to be satisfied with their gains and take their profits.
I have been following the company for thirty years but have not been a continuous shareholder all of that time. I was on an airplane rummaging through the reading material in the pocket in front of me. Someone had left a copy of that old, right wing rag called "The Spotlight" in the pocket. I had never heard of it, so I pulled it out and started reading. An article about Medizone appeared. The Spotlight writer reported that Medizone had received FDA approval to begin clinical trials for its ozone blood purification process. I checked it out when I got back home and found out that the company did NOT have FDA approval to begin clinical trials. I remember calling The Spotlight and asking it to print a retraction.
I wasn't very familiar with the 510k regulation until it popped up with Medizone. I started reading a lot about it. I guess I could be wrong, but I get the impression that it's similar to the normal labeling issues that come with new drugs getting ready to hit the market......except it's for medical devices. Hey Elis.....what's your take on it?
A lot of opportunities exist in the biotech world today. I don't think our newest board members would have bothered with Medizone if they thought the 510k situation was insurmountable or our new CEO wasn't committed to making things happen.....in our lifetimes.
The years of inaction on all fronts are over, given the placement of the two newest Board members. These guys mean serious business. I hope there will be continued housecleaning on the BOD and look forward to the results. Innovasource and EMA are working on Medizone's future. We never have had anywhere close to this type of expertise in-house or outside the house. We're all impatient, but we must remind ourselves that we are basically starting from scratch. "Scratch" means still dealing with government, creating global awareness, establishing testing in the U.S. and abroad, weighing demand/usage/efficacy that will determine pricing, and just plain getting out there and getting after it.
The stock has given up close to 50% of its run-up after the announcement of the company's successful P2 test. The proposed dilution and subsequent quiet period have done their jobs. It will be interesting to see where the stock bottoms during this cycle.
Low-priced stocks are low priced for a variety of reasons. That group, as a whole, is driven by news. When the news dries up, so do many of the stock prices. AUPH really has had a meteoric run off a Phase II test. Given the time it normally takes to get a fully enrolled Phase III test off the ground and running, one would expect a lot of quiet periods when it comes to news. So seeing AUPH's stock price beginning to trend downward some isn't unusual to me. What the market did tell me was that there was a bit of "irrational exuberance" at $10 and a bit more real value in the 6$ to 7$ range......where new accumulations are taking place.
We're all getting a little impatient with DE, because we have waited so long for something good to happen. Had I been thrown into the CEO position, I can only imagine what would have been cluttering my pea-brain on the first day: Global awareness, marketing arms, testing, where the company REALLY stands with the regulators, an unattentive Board, existing distributor contracts, investment banking, potential suitors, etc. etc. etc. Hopefully, in the next few weeks, a few of these vital areas will be cleared up and off and running. What bugs me the most, right now, is that there doesn't seem to be any real life testing in sight, and we're still dealing with a part-time CEO. Shareholders deserve a CEO who will go to work every day on their behalf.
There are ways to raise money. The old regime used to be able to do it until confidence finally waned. One would hope the new regime would have instilled more confidence to the point of increasing cash flow.
There are various forms of "secondary market" transactions that would not show up as normal market trading.
The 10Q is due to be released in a few days. I think it boils down to whether or not our new manufacturer built any machines for the cause. The 510 report should be answered by now. Maybe we get a report on testing, and maybe not. If not, then I guess no news is not good news.
We have a new FDA commissioner: Scott Gottlieb. He served during the Bush 1 administration. The new "21st Century Cures Act" should help every company trying to bring a viable product to market. It is designed to streamline the review process, snip unnecessary red tape, and make "real world" experiences part of the decision making process.
Scott Gottlieb has been cleared to be the new FDA commissioner. He served during the Bush 1 administration. There is a new law on the books: the "21st Century Cures Act". The purpose is to streamline all major avenues that lead to the final decision process and reduce red tape. The law also refers to "real world" events that should be part in that decision.
Glickman seems to be an advocate of transparency for shareholders. Way too often CEOs in the penny world hide behind a variety of facades and dish out just enough erroneous information to feel entitled to collect their next paycheck at shareholders' expense.
I am newbie following this company and am impressed with everything I have read so far. I just don't want any part of any governmental body screwing up the process. The fact that a big boy like Lilly is out of the picture, and no other big boys are in there competing, means that Aurinia has a better shot because of fewer "distractions" at the FDA. If Phase III efficacy maintains where Phase II left off, we could have a very big deal on our hands.
I am hoping that the FDA allows Aurinia to complete the expanded Phase III process so that no stones are left unturned. Again, historically, the FDA has asked companies to stop in the middle of a test and bring them the preliminary results just to shoot them out of the water and make them start over again with the same test. We don't want that to happen. My reading of the literature tells me that the Phase III test is designed to succeed. What we don't want, again, is a wary FDA that comes in and tells the company that the Phase III test isn't as far removed from the Phase II test as it should be, so protocols need to be tightened and the test needs to be repeated. Hopefully Aurinia has a team working with the FDA to make sure everyone agrees on the protocols. Once the first indication for the product is approved, its new familiarity should help additional indications be perused a little quicker.
We have had very meaningful commentary the last couple of days. I'm happy to see some cautious optimism in the audience as well as, what Mr. Greenspan referred to many years ago, "irrational exuberance". Phase III can be a crazy place to be. History will show companies that had minimal side-effect issues in Phases I and II and then stopped testing in the middle of Phase III because an overwhelming number of side-effects popped up. Other companies showed decent efficacy in Phase I and II but didn't reach the necessary endpoints in an expanded Phase III. I had forgotten about the Lilly attempt. What that failure should remind us of is that both large, established companies,with plenty of FDA connections and smaller, specialized firms with few connections had trouble developing a product to effectively treat Lupus. I have had friends suffer from both the kidney infections and the muscle fatigue. It looks like the products that have been approved deal with muscle fatigue and the overall immune system. A successful Phase III test on the nephritis issue could be a major gift to the world.
We have to bear in mind that just about anything can and has happened in a Phase III scenario within the biotech industry. Historically, it has been tough for companies to get a foothold in the Lupus area, especially where the kidneys are involved. Go into your favorite search engine, and you can see the biotech industry carnage related to Lupus development. LaJolla is one of the most famous failures. A drug called Benlysta is approved and is claimed to be the first lupus treatment in over 50 years. A 26 year old cancer drug, Il-2, that isn't used much for cancer treatment anymore, is being touted as a potential lupus treatment in the form of an overall immune system builder. So Aurinia seems to have great promise in the area of nephritis. What are the possible negatives related to the upcoming Phase III enrollment?
You're welcome, hp. Aurinia looks to be a company with some solid prospects. I have followed biotech for many years. It can be a very tough road to hoe. I remember companies like Hemispherx and LaJolla who spent twenty years working on treatments for CFS and Lupus. So I am encouraged by how fast Aurinia has come in its development of a lower tract method for fighting lupus.
Whoa....let a newbie in to work on the latest question. Short term capital gains equal ordinary income tax rates and can be from 10% to 39% for assets held for less than a year. Depending on income brackets, long term gains can run from 0% to 19%. Waiting 30 days to repurchase a stock only is important if the original stock was sold at a loss. A 31 day "wash sale" rule takes over. Should the stock be repurchased before 31 days have expired, the capital loss will not be able to be deducted. When one has a gain, a stock can be repurchased anytime after the sale without consequence, but the gain is still recorded. The IRS rules are all over the net.
You're obviously short and looking for reasons for GTHP to fail. There is no reason to exercise any warrants and further dilute the stock at this point. The stock price isn't high enough to make it worth anyone's while to do so.
Warrants have to be "in the money", i.e., worth converting, first. Another reverse split? Highly doubtful. There's hardly enough of a float today.
If a 510 needs to be filed, it should have been filed shortly after the Belleville test .....almost four years ago.