thinking this will turn out pretty positive.
OK,so all the various venues must approve the enrollment in the trial.
With each approval, we get closer to actual enrollment.
Each benchmark will maintain investor interest and likely increase the PPS, or at least maintain it at higher levels than it's been.
Even bashers will have to agree with that.
Then, as enrollment ensues, as the 3 benchmarks are met, Cel Sci execs get shares. I think Geert actually gets the lions share (as he should) as enrollment increases *1/3, 2/3 and complete).
No dilution as those shares have already been issued and accounted for. So once again, bashers will try to talk it down citing dilution, but it's not so.
Here's my kicker.
As we get into the trial, let's just say, the FDA is on the fence, however, there are 8 other countries who may "like" what they see.
Any of them could approve the drug even if the FDA doesn't, right?
Someone correct me if I'm wrong but this is a pretty ingenious plan that increases the probability of an approval....somewhere.
Any comments or has this been discussed ad nauseaum?
There will be approx 48 sites conducting the clinical trials.
That's around the world.
As an example, what do they do say in Turkey if one of the sites has 17-18 patients and 2 exhibit what amounts to complete remission. Meaning their tumor essentially is gone. And 1-2 others exhibit 30% reduction in tumor size.
It may not affect the entire trial, but Doc at that site will be clamouring to have MK approved immediately.
Now think back to Phase II.
Only 18 enrolled as many folks have argued about.
We have 800, but at any one aite we have the equivalent of what we had before in P II.
ARe the chances pretty good 1 out of 48 sites will repeat with similar results?
I'm just making an argument that regardless of how the entire trial works out, the odds of success at any one site are VERY HIGH and thus the potential exists for success in another country regardless of the results of the entire trial.
Someone like AF could make an argument that's why the trial is flawed IF this happens (he didn't try that one yet), but one could also agree with what I'm pointing out.
And don't forget about the Named Patient Program that CVM talked about a while back (1 year or so?). CVM was making a push to get this idea established in some of the oil-rich middle east countries. But the entire program dove tails into what you are talking about with various countries (if not all) meeting with success and having patients start to ask for MK.
"Any of them could approve the drug even if the FDA doesn't, right?
Someone correct me if I'm wrong but this is a pretty ingenious plan that increases the probability of an approval....somewhere."
- the european union will follow the FDA guidance regarding ph III as per the mutual agreement in place. Than the drug approval will follow a specific european path once ph III is over. I believe Israel is in the same scheme (Confirmation ?)
- regarding others countries approval, I am not a specialist of turkey, russia, or asian countries but I believe firmly that early approval would be possible on positive interim data. Countries like South Africa have less strict restrictions on drug approval(I remember for instance the use of Hemopure was authorized there and nowhere else). The Byron deal makes sense for a quick ROI in South Africa
1-I don't think it decreases the time for the study, but as I pointed out once before, end points will look to be met but along the way, tumor reduction, tumar markeer reduction and blood chemistry levels can cause early decisions on the basis of humane actions needed if MK proves to show efficacy early. So I don't think the number enrolled impacts on the time.
I DO BELIEVE the number of sites increases the chances for approval, as well as the possibility of confusion over the controls. Just a negative I ponder over. Many sites. Many. Could possibly cause alarm on controls.
2-However, the number of site and number of countries increases the likelyhood of a win somewhere if not a complete win.
I am liking what I am thinking about.
The odds for an increase in PPS just drastically increased in my thought process.
I'm trying to see where I'm being overly optimistic, and I can't.
I don't want to sound too bold but think it through.
This is a good plan.
Kudos to management and the CRO.
And the possibility of approval in other countries is very high as many don't have the same level of care we do.
However, that said. MK is not going to fail anywhere. MK is going to change the way cancer is treated.
Your correct. There are some articles out ther where AGEN was denied by FDA but received approval in Russia. No other countries want there drug. I think at one point there stock was almost $3.00 or more after they announced that awhile back. Of course AGENS drug Oncophage is no Multikine.