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I would not be surprised at all if the FDA made them start at P1. The clinical data is very old and probably not done under the same protocols that are required today. The fact that the trial material is different then those used in the late 90's trial (although the current material may be superior) could be a big problem. This stock cannot take a bad news hit at this level. Those who pretend to "not care" about the stock price are not being honest as the lower this goes the point will come where raising money will be impossible.
The ONLY focus this company should have right now is proving CIAB works. If the P2B trial is successful it will open up all of the options and resources they will need for other applications if it is not successful then it will be over for this company and all of the CIAB rights will go back to Austrianova or whoever gets them in bankruptcy court. I do agree that you better get it right the first time because a company this small with no cash only has one shot but allowing the PPS to dip this low has also created a cash problem. Yes i do blame Kenny Esq for this as he should have raised the cash he needed when he could of. Many companies raise the funds they need well before clinical trials. Now he is playing a very weak hand with anyone willing to fund them and that always is bad news for existing shareholders.
Standard Costs (in thousands of dollars) not tens of dollars. Thanks for proving my point.
Really?? I am fairly sure that the people that are preparing the pre-Ind and then the Ind charge actual money. Also i believe the application fee to the FDA for a new treatment is 500k. Then there is paying for all of the pre phase 2b training at every site. Then the payments to Austrianova to produce material and for the cell bank company. Believe me there is a lot of money that will need to be spent before one patient is enrolled in any trial.
Men et Manus The most reasonable post i have read in two years.
Still no satisfactory answer on paying for clinical trials. 1.3 Million $ in available cash is not going to cut it and their ability to raise cash without their ATM is very suspect.
$8,000,000 paid to just two employees over the past three years. That is from 2013-2016 $8,000,000 in cash and stock. A 30% raise for Kenny esq from 2015 pay rate. $1.3 million left in cash after paying current liabilities and no current viable way to raise cash. I would say this is a HUGE problem. At 67 and 75 years old are the two leaders of this company trying to build a company or build a giant retirement fund.
I sure hope that Gunzburg, Salmons and Lohr are not pulling the strings given their horrible track record of succeeding with this technology and I am starting to wonder about Hidalgo if he didn't even know what the standard of care was for patients no longer progressing and had to be told by other Oncologist's. As far as Crabtree goes you of all people should know it was Dr. Ryan that hired Crabtree not KW. You know the famous Dr. Ryan that was going to cure cancer and MRSA with his natural treatments. Where did he hire Crabtree from do you remember? He was the COO of PhytoCeutica another all natural chinese herb cancer cure company.
You can spin KW's CC any way you want but the facts are that he has been here for three years and for those three years has been promising trials soon. Now I can understand delays for events that happen with bio techs but the excuses that we hear from KW are ones that show why he seems to be in over his head as a lawyer running a bio.
1-We didn't realize the population in Australia wouldn't support the P2B so we had to start all over again with TD2.(A CEO of a bio tech doesn't know this?)
2-Austrianova needs to complete the process of Cgmp before we can move forward with anything. (This after announcing two years ago that trials would start in 2015 while knowing this was impossible because there was no way to produce cells)
3-We will be in clinical trials for diabetes in 2017. (Meanwhile his own team is writing an article saying human trials are 3 years away)
4-We will know trial locations in 2-3 weeks in an interview 8 weeks ago!!
5-Its a biologic so we have to make sure everything is perfect before we go to the FDA. (a)what have you been doing for during the 18 months waiting for Austrianova? (b)You don't know this information? Haven't you been telling us for three years about the previous clinical trials? Are they so old that this data was not required back then? Were these trials even valid? Is this even going to be a P2B or is the FDA going to say no start at P1.
So you tell me has he been lying or is he just out of his league!!
We don't know when pre-ind will take place because there is much work to be done because its a biologic but we will start clinical trial in q4 ????? Good lawyer double speak.
Forty five min of my life wasted so far. three years of planing for a phase 3 and than a phase 2b and still so many things not done it is sad.
What needs to be done before a pre ind meeting Kenny esq "a lot". This trial is not happening in Q4 who are we trying to kid?????
I did my DD and it is exactly what i said. The reason this company traded in the .20's a year or so ago is on speculation and the reason it is trading at .05 now is not hitting target dates they set for themselves. Its not manipulation its lack of believers.
The market cap of this company is 40 million $ there are many companies out there that have a similar market cap that are much further along than PMCB. PPS is irrelevant. I happen to think 40 million is high compared to what they have shown in progress.
I will never understand the short manipulation theory that is commented on so often. This site and every other stock site consistently show that the short interest is very low. Why can people not understand that the PPS reflects what a company has accomplished for real not what they claim they will accomplish.
Call it what you want but the question was answered by email so i have to assume its accurate that no Pre IND has been set with the FDA as of today.
I would assume that investor relations would not lie to an investor but rather just state thank you for your request for information the company will address all information about planing for and conducting clinical trials via a press release to all investors.
The email confirms that they have not filed a pre Ind with the FDA. Which makes me think they have not found a Primary Investigator or nailed down clinical trial sites. Mr. Waggoner better have a lot of information and explanations next week in his CC. I find this lack of progress troubling as the company has had over 18 months to plan since Austrianova opened their facility which includes three months since they got Cgmp. The biggest problem i have with the CC is that it is not open to live questions and follow up questions from any analyst that might have called in. The call could basically be recorded at any point and played next Thursday. The company really needs to be much more transparent with information not just releasing "feel good" PR like the interview 7 weeks ago where they clearly stated clinical sites would be released in the next 2-3 weeks.
You are correct. It was a few years back they issued shares to settle a dept if i remember correctly for the building they owned, It was in one of their 10k's. It ended up saving them over a million dollars so if your question is would this make it difficult to borrow money i am sure their credit history would make it difficult.
Enjoying the conversation BioNewton. You don't often get one on these message boards if I don't find the time to get back on today you have yourself a good day.
Holding shares because they are long or not willing to move on because they are so far underwater.
If you are waiting for the call for great news to be released then i would argue that a Thursday afternoon in the summer after the market closes and before people are out of work to listen to a live call is the worst possible time to do it. The market is dead on Friday's in the summer and by Monday news is forgotten. I would hope that positive news is released on Wed. Thurs and then talked about in detail Thursday.
My opinion on why we are dropping is that during the interview at the Marcum MicroCap a statement was made that they would be announcing trial details in 3-4 weeks. It has now been 7 weeks and no information has been released. People that invest in OTC stocks have a very little patients and when companies continue to make statements and set milestones and then don't hit those dates they move on. Allowing the share price to drop like this would be of no concern to a well funded company as they would not need to raise capital but this is not the case here and allowing the share price to collapse here is a big problem.
Don't worry about that I have submitted multiple questions that I feel need to be answered.
Saying that the trial will be stopped at 6 months is also a misleading statement and the CEO should also address this next week. A trial length is based on total enrollment what the primary endpoint is (is this case progression free survival) and how quickly they can enroll patients. To say a trial is only going to last a year with a 6 month analysis is a "best guess". Anyone who invests in bio tech should know that. Patient participation is declining every year while new clinical trial numbers increase. So far this company has not met one milestone it set for itself and the stock price has suffered badly for it to the point that even good news is met with disbelief by investors. As shareholders we should demand well thought out milestones and hold management accountable to hitting them.
The trial is a year. Every trial has an interim analysis for futility or efficacy. Why would you spread a lie about private funding? My point was not about diluting the stock it was about finding a market for 300,000,000 shares. Are you fine with it if the have to sell 800,000,000 shares at .02 because that's the kind of discount price it might take to raise 16 million $. What i want is an honest answer from the company on how they will raise the funds. As shareholders we have that right.
To say the funding is not an issue is foolish. The company is spending approx. 2 million $ a qtr. without any ongoing clinical trials. For a year long trial that will probably cost 8-10 million the company will need to raise 16-18 million $ over the next 12 months. At .055 a share that would require them to sell about 300,000,000 shares just to fund their activity over a 12 month period. Even if they could use their ATM the market for that amount of shares is more then this company trades in an entire year. If the funding question is not answered in a clear fashion next Thursday then the call will be totally useless.