Trying to stop a delisting using a reverse split is a strong indication that a company is in trouble--stock price dives because of lack of demand. Lack of demand means a company is not executing. Getting this on Nasdaq--especially with Brilacidin--will get the company noticed. More institutional investors decreases the "retail investor float". Because of Brilacidin, I believe analyst would be all over this when midterm phase 3 results are released. Moreover, price targets could be set thereby bringing in more investors who will never invest in an OTC stock.
The way I found CTIX was because the CEO said 3 years ago that he was going to uplist. I'm getting tired of waiting and he hasn't provided any logical rationale for his reasoning. He insists we'll get there on a major price move. But he doesn't tell us what the price is that he is looking for. Based on stocks I've invested in the past it was $3 and $10. My guess, he's aiming to hold $3 for 5 consecutive business days. That is a criteria that Nasdaq requires. We already did that and didn't uplist. Why? My guess there were governance issues that were not cleared. That's why we had the recent shareholder vote and they needed committees as mandated by Nasdaq. You have to ask the question, "why didn't the CEO ensure that the requirements were met before applying to uplist?" He was either poorly advised or sought no advise. With respect to the $10, the CEO of another company stated he needed that price to attract healthcare investors on a higher market. He executed a 4 for 1 reverse split.
I just call it like I see it. In the past I have written CEOs and criticized their actions and/or inactions. Some receptive some not. In this case, I believe it is pointless. I'm still in for the pipeline, but at the end of the day, it's all about how the company executes. If execution continues to falter, I'll have to put my marbles in another company where the CEO resigned and the new CEO is executing
He had a severed spine. You didn't look at the slide as you were told to do otherwise you wouldn't continue with your rant.
The reason they will be able to get $100K is because of the medical cost and improvements in quality of life that the scaffold offers over their lifetime. You clearly don't get it. With respect to the green monkeys and hemisection, it would take a year before they regained function. The scaffold allowed the monkies to walk again in about 35 days. As for inaccuracies, you are the only one spewing them here on this board. When you resort to name calling, everyone can see that your arguments are baseless and since you have no retort to my case about developmental biotechs, you obviously agree to everything I said about them and that you are not an investor, you're here to save us from oursleves, developmental biotechs only trade on news, good, bad and no news, which you were totally unaware of otherwise you wouldn't have started your rant in the first place.
As for your response, it is laughable as it is not based on any facts. You miss the whole point because you have a biased view. Apparently you are much smarter than the CMO, CSO, the doctors that are participating in the trial. Yes even I knew that the monkeys would gain function back with no treatment after year, but because of your blinders, you can't rationalize how these same monkeys could recover with in a few weeks after the scaffold was inserted.
As for Jordan, here's a little something you didn't know--he had a severed spine--yet has the best recovery so far and his recovery even at 12 months wasn't continuing. So in case you missed it the first time I posted this, see slide 6.
As for price, developmental companies stock prices trade on 3 issues, good news, bad news and no news. It appears you don't know this. You can take many a developmental company and say the same thing. Lets take CLLS for example. Has a very promising cancer treatment. Debuted in March of 2015 and closed at $39.30 now it's in the low 20s soon to be probably trading in the high teens. So please don't try to win a disgreement by throwing fear into a discussion as it shows your lack of experience in investing in developmental biotech stocks. But I take it your just here to tell me here their wasting their time while you wast your time telling us that were wasting our time. I really don't understand why your type just can't move on once you've made your point. People can make their own decisions. If the company has a laughable presentation, why do you even bother to comment? Essentially you are calling them liars. Shouldn't you just contact the SEC and stop bothering me and everyone else with your dribble when the facts don't go your way?
IMO, and CTIX doesn't provide this information, but it all comes down to possible revenue stream from a given pipeline. Difficult to treat cancer is a big deal. Good news on cancer drug, stock would move. But eventually it will fall again as developmental companies stock prices only react to 3 issues, good news, bad news and no news. Phase 3 drug price move up and then settle back down waiting for revenue stream to build. But without analysts to put a price on CTIX, it makes it hard for the retail investor to judge what a good price is or isn't. Hence again, uplist.
Even if Brilacidin passes phase 3, we really don't know how well it will do both stock price wise or revenue, but I do suspect that it will do well on the revenue side mainly because of the reduced possibility of resistance. And as a parent, I prefer a 1 day treatment verses 7 to 14 days.
I know you're a hater, but I hate to agree with you, but I do. But what I didn't like in the article is this misplaced fixation that a reverse split is a bad reason to uplist. It has no impact on market cap and it allows the company to be on the Nasdaq when it hits significant milestones. Additionally, it reduces the float thereby increases price pressure, a positive, on shares. Shortening a stock with a low float, well, the stock flies high when the shorts are wrong. Moreover, many mutual funds and alike have minimums on stock prices for companies that they invest in, e.g. $5 - $10. The CEO's position is that I will make us achieve these milestones here on the OTC and then move up. Most companies would rather make these achievements on a higher market so as to get companies to investment in them by getting better coverage on a higher exchange. Will Black Rock, Vanguard, Fidelity, etc even look at CTIX down here on the OTC? My experience is no.
It is highly unlikely that any major players will buy into CTIX until it is on a higher exchange nor will they even know much about the company while it's on the OTC. The only time a reverse split is bad is when a company performs one to prevent it from being delisted from a higher exchange. Because of this issue--and this issue alone, I decided to sell nearly half my position and move on to a Nasdaq company that actually has conference calls and analysts that follow them. IMO a company can have a great pipeline, but as long as it is on OTC Markets and all the achievements are made there, the big investment companies can't notice even if they wanted to.....I have to wonder if this notion of a refusal to uplist has do more than just pride....maybe after March 2016 he should reconsider uplisting.
The company has already stated they will address the ENTIRE acute population in 3 different ways.
1. The CMO has already said this during the "Key Opinion Leader and Company Update Webcast"
2. If they weren't going to go beyond AIS A, there would be no need to seek a PMA. They would just stick this HUD and the 4,000 number.
3. Slide 31 of the current corporate presentation speaks for itself, but in case you missed it...
Premarket Approval (PMA) path...ability to expand to ENTIRE acute SCI population (complete and incomplete thoracic and cervical injuries)
4. Slide 47 of the current corporate presentation speaks for itself as well. If they were only going for HUD, they wouldn't use projected revenues of $600 mill -$1.8 bill.
Now, I think there is a chance some will walk. In the green monkey trial, a monkey wasn't treated for FOUR weeks, but it had a hemisection and was able to climb a ladder and one could clearly see the previously paralyzed leg and foot function as the it climbed the ladder.
We all like to assume something when investing in stocks. My assumption was based on the green monkeys, but I had to reevaluate my position with Jordan. It was with him that I learned that walking wasn't the most important issue that needed to be addressed for these patients and that there is NOTHING currently approved that will help.
Unfortunately Miker isn't with us any more to point out things that were obvious to him, but not to us. One thing I liked about him, is that he liked to do his homework and share it with us so we didn't make bad decisions. To be fair, I only caught on to this because of 1 above, but 3 and 4 were there all the time.....
Do some research on Geron's Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury as well as studies being performed by Neuralstem and Stem Cells Inc. Here's a hint Geron stopped enrolling patients before they reached complete enrollment. Why? Let's just say it wasn't for safety reasons....and if you so fixated on walking, you might as well sell or wait a minute...if patients with AIS B or AIS C or D get treated with a scaffold, could they walk? Aren't those patients functionally equivalent to the hemisection model that we witnessed in the Green Monkeys? ??????????????????????????????????? Partial paralysis?????????????????????????????
It will be interesting to see if Kevetrin by itself can STOP or reverse the growth rate for longer than 3 months when treatments are given over a longer period of time....
People with cancer of the pancreas who can’t have surgery may receive a type of drug called targeted
therapy along with chemotherapy. Targeted therapy SLOWS THE GROWTH OF PANCREATIC CANCER. It also helps PREVENT cancer cells from spreading.
You evidently don't understand what the FDA is saying when it discusses efficacy with respect to the criteria for data concerning patients in a Phase 1 trial. It is the following:
"In order to designate a product as an orphan drug, the scientific rationale portion of the designation application must include enough information to establish a medically plausible basis for expecting the drug to be EFFECTIVE in the rare disease. This is BEST supported by clinical trials of the drug in the rare disease or condition."
efficacy: "capacity for producing a desired result or effect; EFFECTIVENESS"
Clinical trials normally consist of 3 Phases. Phase 1 data was used.
In the case of the pancreatic cancer data, CTIX provided efficacy data for both rodents and a human being. With respect to the patient, anyone that has been through or has a relative or friend go through cancer knows stabling or reducing tumor growth is a demonstration of effectiveness--especially in late stage cancers.
I only deal with facts when it comes to developmental stage biotech companies and I don't read information into or out of reports, guidance, rules, regulations, trials that isn't there in the first place when assessing the potential of a given treatment. You're bias is so strong as based on your current and previous comments that it is difficult to take you seriously. You use the rodent data to support your argument and are dismissive of the patient data for the same reason yet you provide no logic for why suppressing tumor growth is not a data point. Potential doesn't mean it will get through Phase 2, but it has met the mark for a Phase 2 trial and Orphan status. If a company can only demonstrate safety, then I will pass on it. Animal data is fine, but I look for human data to cut down on my risk--and IMO CTIX has it. "It" equals The patient, who was diagnosed with pancreatic cancer received four full cycles of Kevetrin. Tumor measurements showed stable disease for more than three months
So the pancreatic patient had 4 cylces over a 7 week period and after 3 months "Tumor measurements showed stable disease for more than three months."
The goal of cancer treatment is to cure, but we are entering a phase where it will become a chronic disease. If Kevetrin can be applied in such a way that this disease can be managed early on, alone or in a combination treatment, then I see good things in the future. What isn't clear to me was whether the maximum dose was applied. But in any event, Phase 1 is not powered to cure patients. Very good news IMO.
Orphan Drug and Orphan device designations have significant time and revenue advantages. If a product is given orphan status, the product gets 7 years market exclusivity in the U.S. In Europe it's 10 years. Additionally, the process (time) of getting to market is sped up, e.g. quicker FDA reviews and alike.
The regulations say that the sponsor is required to submit all relevant data about their drug, why doesn’t the sponsor have to submit animal toxicology data for orphan designation?
- In order to designate a product as an orphan drug, the scientific rationale portion of the designation application must include enough information to establish a MEDICALLY PLAUSIBLE BASIS for expecting the drug to be EFFECTIVE in the rare disease. This is BEST SUPPORTED BY CLINICAL TRIALS of the drug in the rare disease or condition.
- However, IN ABSENCE of human data, the application for orphan drug designation may be satisfactorily supported with COMPELLING preclinical data that uses the active moiety or principal molecular structure of the proposed orphan drug in a relevant animal model for the rare human disease. Animal toxicology data, which describes the safety of the drug in animals, DOES NOT provide efficacy data, so IS NOT useful in supporting the scientific rationale section of the orphan drug designation.
It’s clear from the FDA answer that human data (Phase 1) is preferable and that some demonstration of efficacy is required, i.e. no efficacy data means a company does not have the SCIENTIFIC RATIONALE to support orphan designation.
Sentiment: Strong Buy
If you take a look at slide 8 of the BioTech Showcase 2016 presentation, you'll notice that Kevetrin outperforms Paclitaxel (Taxol) by reducing tumor size on average by 98% vs Taxol 91%. Assuming the dosing for Taxol is the same as a standard treatment for breast cancer that was compared in Phase 1, Kevetrin possibly could be better treatment vs Taxol, Abraxane and Ixempra. So if you read this article in the context of the above, you'll get a sense where Kevetrin stands with respect to other breast cancer treatments.
So why not target breast cancer right away? A couple of reasons, it will take longer to get to market since Kevetrin can't be granted Orphan status for breast cancer. Secondly, too many other approved drugs to compete with; however, if the side effects are not as bad as the other drugs, Kevetrin, if efficacy holds up, can challenge the approved breast cancer drugs at some point in the future.
Sentiment: Strong Buy