Wow!Wow Steve you really know how to make an entrance. I'm sorry that I wasn't around to respond to your posts earlier but it's been kind of slow on the board so I thought it would be ok if I took the day off.
To answer some of your questions... I have been conspicuously missing for a couple of reasons.
In May, I along with others took a pretty big hit and for some strange reason I didn't feel like posting... I didn't want to argue with bashers and I didn't want to influence anyone else's decisions. I didn't sell but that is because I was prepared to hold... I did not want to influence anyone else or be responsible for their buying or selling. There were many that I was still in contact with... but not publicly.
Since then I have posted every few days, unless I have been away...it is summer. In other words, nothing sinister.
Now to address your posts
The "placebo-effect" was not good news in any way that I read it. Let's face it, the placebo had better results than REGENESIS and this was a much smaller patient pool than originally anticipated. The actual chances of the FDA giving a Phase III clearance on this is HIGHLY UNLIKELY. In my experience, the FDA likes to see a good portion of positive impact from a trial drug over a placebo; not just that it was almost on par with the placebo.
If you had read anything about placebo you would know that sample size is a big factor.
"For the trials with continuous outcomes, placebo had a beneficial effect, but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials."
As for the FDA...
According to the FDA approval process, it doesn't matter how many times a drug fails to prove useful in its clinical trials. Innumerable scientific studies can show the drug to be ineffective, but as long as two or more show statistical superiority over placebo, the drug can win approval.
SCT has a drug that is not toxic, has no side effects, and is needed because there is no other drug in the space that can treat 100% of the patients. This was not a Phase III trial... as long as they can use secondary end points, historical data, and come up with a strong phase III trial protocol, they should be allowed to continue. As I have said in the past the FDA will probably request a large sample size and may require more than one study for phase III... not uncommon.
Reread the phase IIa results... this trial exceeded what was considered clinically relevant improvement.
https://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=SSS&t=LIST&m=28332140&l=0&pd=0&r=0
Placebo isn't the only factor Randomization can also effect results..
It also becomes immediately apparent that absolute precision is required when randomly allocating patients with lower baseline NIHSS scores (0-15) to treated and placebo groups because a mere 1- or 2-point difference in baseline NIHSS scores between two groups of otherwise equivalent patients who have mild ischemic stroke could result in a 10% to 20% difference in the expected probability of an excellent outcome based on chance alone.
This issue worked to tPA's advantage...
can't think of many company's that would want to buy-out such unlikely prospects
Really, did you know that Japan has a stroke drug that has never been tested against a placebo... they were so desperate for something that they approved a drug without proving efficacy.
"The use of edaravone to treat stroke remains controversial, mainly because there have not been randomized double blind international trials to support the use of the drug."
What I do now from my experience over the past few years is that there are many pharma companies out there with many products. The vast majority of these products fail and never make it to market. I have seen far more effective/positive results on differing drugs that have not been granted Phase III
Many drugs fail at the Phase II level, I get that. Name 3 that had effective/positive results that were not allowed to move on to phase III. Here are three that didn't have good results that did move on...
Prozac
https://books.google.ca/books?id=DQ52lquMnE0C&pg=PA41&lpg=PA41&dq=prozac+%22placebo+washout,%22&source=bl&ots=jDW-Ny_27K&sig=rKFO8WyqD3N2fqd7yOTafhdenB4&hl=en&ei=4HVKTLvsA8P-8QaJtfTJDw&sa=X&oi=book_result&ct=result&resnum=1&ved=0CBkQ6AEwAA#v=onepage&q=prozac%20%22placebo%20washout%2C%22&f=false
Dendreon failed to meet it's primary endpoint 3 times and went on to get FDA approval.
tPA was approved... maybe you should read about their FDA journey.
https://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=SSS&t=LIST&m=28340060&l=0&pd=0&r=0I
As you can see, the number of people involved in their Phase II was closer to the numbers required of a Phase I trial. As you can also see, it is possible that the drug could advance to Phase III given the objectives of each stage (Phase II focus on effectiveness vs. Phase III focus on risk-benefit). However, unless the drug suddenly has a miraculous improvement in effectiveness, it is unlikely to do well in Phase III, if it even gets that far.
Phase II trials are performed on larger groups (20-300). Look at Prozac... "It is astonishing to realize that the approval of Prozac was based on fewer than 300 patients culled.. from the original cast of thousands.
However, in terms of the reliability of KayDay (who is conspicuously missing in all this discussion and action of late), their reliability is questionable at best. I refer back to their last post where they indicated 3 companies who had went on to Phase III and their stocks allegedly soared. Let's take a look at how these stocks are performing now:
The simple fact is that "KayDay"'s picks and justification for optimisim for October is unfounded. All 3 companies have tanked; would you consider that reliable advice based on strong past performance?
Had you read past posts, I was asked to find examples of stock rising due to an end of phase II meeting or the announcement of phase III. The companies were to show an example of what could happen on good news. My point was that good news in October could effect the SP. I posted the companies, the date of the NR, and the SP before and after.... in no way were these stock picks, or examples of future successes.
Lastly, SCT has more than just money.. The Company currently owns 86 pending patent applications, eight issued U.S. patents, four issued Australian patents, two issued in India and one issued Japanese patent. These make up 15 patent families which have been filed in the U.S. and internationally.
I hope that answers your questions...In the future if I don't respond it is because you are on ignore!