Of course I am with you on the majority of your post--I find the PR to be very good news. Considering that HemaXellerate is the first of several treatments for various diseases--diseases that command medical treatments in the multi-billion of dollars per year--once the FDA gives its stamp of approval, because of the nature of the treatment and that OVERALL the HemXellerate approach is found to be safe, the other treatments derived from HemXellerate will be a cake-walk.
Further, how anyone could look at that PR and conclude this means the treatment is a no-go is beyond me. Or, how anyone could read it and conclude that it will be months before they complete the Q&A. Though few really understand how the FDA works most if not all should understand by now with the information that has been provided that this is a very time consuming process. As I have noted before, before e-filing with the IRS, it could take months before people saw their tax refunds in their mailboxes. Even with e-file it can take weeks or sometimes months. We are talking about being granted approval to conduct medical trials on human patients by one of the most scrutinized agencies in the world. They are not going to rush anything for anyone.
That being said, the company filed their answers to the FDA's first set of questions on 20 May. One month later on 21 June, they received a further questions of which Dr. Koos had this to say:
"we received a second set of FDA comments stating several of their questions were adequately addressed, however additional data needs to be submitted,"
The PR then states:
Based on experiments that FDA requested, the company generated new data further demonstrating efficacy of HemaXellerate I™ in animal models. This may be seen in the figure attached.
It does not say they are currently generating the data. It says the company generated. Which pretty much states that what the FDA required the FDA now has. Now they are in hurry up and wait mode. But how long do they have left to wait? Months? Weeks? Days? No more? Fact is, no one knows. Given by the amount of time between Q & A up to this point, I am guessing not long at all.
The only thing that was left to further clarify was efficacy of the treatment. Not safety. And efficacy has been proved by the already generated data.
Surely no one expects a PR where the CEO of a biotech states "welp, I told the FDA to get a move on it so we will have our answers in a couple of days."? Again, they are exactly where they should be. And for all we know, that seal of approval could have arrived yesterday after the PR.
Those that bailed based on a PR that they clearly did not understand deserve to crying at their screens when they see the price move up after the announcement of trials. And to sound like a curmudgeon myself, I wish I could be a fly on the wall, laughing hysterically at their misery. Especially those who have been pounding on their chest in between insults and attempts to humiliate!
And that brings me to my last point and where I do not agree with your insistence that the boards have little effect on the pps. Within minutes of the PR being released and pasted on iHub, the volume went from next-to-nothing comparatively speaking to (less than 10 million) to a tick over 70 million within a span of, what, 2 hours. The PR had hardly any time to be indexed. You would have literally been refreshing Google or Marketwire every 60 seconds or so to get it when it was since the PR had just been published. The influence of these boards on a penny stock is incredible.
I am glad you were able to increase your position. I have no doubt you will be so very happy you did!
Off to see the wizard...I shall return.
