We all assume the enrollment will begin shortly. Either coinciding with plant validation or some time shortly after. I believe it's a realistic belief and for me, in fact, the only "time element" I need to see met, for now.
After it's officially started, I make no predictions on how quickly results will be reported. I expect it to be considerably longer than most predict.
The FDA does NOT work on a time frame constructed by CVM. In fact, one of the reasons I am patiently waiting is I know CVM re-evaluated how the P III trial will be conducted, following carefully dictated protocols by the FDA to make the P III much stronger than the P II data. They do not want to find out 2-3 years from now that the data wil not be accepted and the trial must be repeated.
Furthermore, anyone who has unreasonable expectations that the trial will report results in weeks or months better get their investment head on straight.
This time they seem to be doing it right and finally have the money; however, I will be very interested to see what the company's burn rate is over the coming quarters to see how smart theyve become in preserving resources.
We know how resourceful they are at bringing in money, but that benefits the shareholders only up to a point. Eventually, the "D" word affects us.
Also, I came to a different conclusion regarding the US partner TBD.
I don't think they have negotiated yet.
I do believe they will be in a far stronger negotiating position a couple of years down the road when real, quantifiable results start to be seen.
Just my opinions and thoughts.
Now when you have a chance, go to the VIVUS website.
Click on Clinical Trials.
Then click on (one at a time) each trial.
You'll see they present each trial, goals, timelines, and it's a great model to follow.
Gives transparency, credibility and a global awareness of all expectations, clearly articulated for shareholders.
Cel Sci should use it as a model for all the clinical and pre-clinical trials.
good points and outlook. i do think that as phase 3 commences and data comes in, anything that seems beneficial will give a boost to the share price. the question is where is a fair share price at each stage and no one knows that. same with the volatility. for example, when phase 3 commences is $2 a fair price? if multikine starts eliminating tumors in 10% of patients within 3 weeks should the pps be $3/share? no one knows these things and therefore it is interesting to wonder if we have successful data if we will ever see the current pps ever again. we all know the share price will tank with bad news, but have no idea where it can go with positive data. my personal belief is that it should hover around the $2-$3 mark if positive phase 3 data comes in for the next few years. the only way i see the current pps holding is if bad data comes in. any thoughts?
And those who hope for spikes in PPS during the upcoming trials better be prepared for what they wish for.
There will be volatility.
And if they wish for spike, then the dips will surely follow.
Tune in to the market cap.
We're at 180 M
Is it too low or too high?
This is my opinion. At the present PPS and market cap, the plant validation has been priced out. If the plant is validated in December, the market cap will increase to approx.200-220 M
If the plant is not validated this month on time, the cap is further reduced to approx. 140M
Your expectations should wrap around an end point.
Determine your end point. Because just hoping for a spike does what? What's your plan if and when it spikes?
I could make a strong argument for holding, and contually dollar coat averaging each month for the next 2-3 years until the day the FDA approves MK for sale in the US or they are taken over. That is an end point.
Or, I could make an argument to sell on every spike hitting the resistance and buying at the support.
We can exchange TA.
On can work or both can work, or not.
Rest assured, there is plenty of time to plan and execute.
This is a open label trial. Results could be given within months after each patient enters treatment. Information such as tumor reduction will be availble within weeks after treatment. As for final patient results we will be looking at 42 months (per FDA and company predictions. I think you need to ask Geert what the company statistations are predicting. Remember, an open trial means that we could see spikes in share values on a weekly or monthly basis. 800 pepole means the possibility of hundreds of positive press releases over the nest 3yrs...Three or five dollars by march...
I ve said multiple time news will be released probally 6 months to a year. And be tumor reduction, which is not the end point but is a big factor and data in the process. Why do I think this? well once they start treatment it is a 3 week process, then collecting data on tumor response and analizing and etc... Why do I think they will release this news, well they said so them selves.
The open label Phase III study has many exciting opportunities for news flow during the study.
alot of other things I have posted will help you
well you are looking at about 20 mill for phase 3 trials.
However, before starting the Phase III trial, CEL-SCI needed to build a
dedicated manufacturing facility to produce Multikine. CEL-SCI has not priced
the Phase III trial in detail, but estimated the parts that will not be paid by
its licensees, Teva Pharmaceuticals and Orient Europharma, will be approximately
$20,000,000. Since CEL-SCI recently obtained substantial financing, CEL-SCI is
moving forward rapidly to launch its global Phase III clinical trial.
I want to add something.
Some folks will bash what I wrote. Some may spout garbage regarding open label trial etc.
There are protocols to follow.
One of them is data collection and reporting.
These take time, and your patience. Do not set unrealistically instantaneous goals.
Also, before they have final data collection, the success or failure of MK is dependent on results.
Tumor reduction is compelling, but does not reflect results.
What will the cost of MK patient treatment be?
Will the average life expectency be increased by 3 weeks, 3 months, 3 years, 5 years?
Well, in order to measure these results, you have to follow the patient and measure the results.
A 2 year survival takes at least two years,then data collection, then reporting..... not 3 months.
Very well spoken. The only reason I'm a current CVM sharholder is the potential of leaps.
I don't think John Hopkins would have agreed to do the study if they did not see potential. The Cleveland Clinics involvment also encourages me.
As far as Maltkine, I don't think CVM would have invested millions on their cold fill facility if they did not feel they have a potential winner. However, the possible FDA approval of Maltkine is a long ways off. The hype and possible leaks of phase three results could bring a modest increase in the pps.
Right now I'm betting on LEAPS being a succuss in treating many different viral and infectious diseases. But with the exception of an EUA for swine flu treatment LEAPS still has many bureaucratic hoops to jump through. Therefore, I don't see CVM being able to bring any drugs to market in the next few years.
But in the long term if LEAPS and Maltkine are successful this will be a great investment. I guess it's a matter of how long you want to hold and will the pps go down quite a bit in the meantime.
Any objective and logical feedback would be appreciated.
I know I spelled Multkine wrong.
True, true, but prior to complete outcome, shareholders can just get encouraging news as it can be made known to support share price above current levels. The bonanza is a year or more away, but we will know much before then too.