Thank you. So much wisdom in your post.
One thing I am not concerned with is the treatments; I am not concerned about the time it may take to complete the additional experiments (whatever they may be) or any additional information the FDA has requested the company provide to validate the safety, efficacy & ownership of HemaXellerate. It is still my firm belief that the extent of the present delays go back to the Oregon State mishap as well as the fact that when HemaXellerate emerges finally, it will emerge with Orphan Drug status. I don't believe there will be an additional wait period for this. I believe when approval is at last announced, it will be so with Orphan Drug status.
I absolutely have 100% faith in the medicine and the doctor's creating it. Their reputations, discoveries and work history speak volumes.
When I discovered the major muck up by Oregon State and subsequently alerted the company to it (yes, that was me) judging by the amount of time it took for the USPTO to update the expiration coupled with knowing how the FDA works, I suspected there would be some major changes in the already processed paperwork. Nothing I found indicated that the application consideration would be halted pending these modifications. At least not in terms of evaluating the treatment...not the empirical data, legitimacy, etc., etc., And even after communicating with several lawyers and people in-the-know within pharma & regulations, I still do not know as the consensus is the level of difficulty will be dictated by the person in charge of the case. Protocol or no protocol, much depends on the person whose lap this submission fell in. That is government for you.
My concern now is Koos. To answer a great number of email and PM's: in short, yes, I am pissed, to some extent I feel used and over the past couple of days I have said to myself "what a dumb ass you are!" as I read through file after file after file of information relating to Koos. Yup, I married the science and neglected to thoroughly vet the in-law before doing so.
See, my problem is I have difficulty in wrapping my head around good people being intimately aligned with a POS. Sure, we all have some indirect connection with someone who is absolutely no good. But, as a person who is the antithesis to most things considered commonplace now (i.e., corruption, apathy, laziness, greed, etc., etc.,) I find it very hard to accept that a truly decent person (or people) can be aligned with people (or a person) whose aim is to inflict harm. The moment I figure out that someone who has entered my life is nothing but bad, I do all I can to rid myself of that person. I don't want to be at risk of being personally damaged nor do I want the guilt my association looming over my head. Ridding myself of such is not always an easy task however. So, discovering what I did about the doctors (professionally and personally) it never dawned on me that Koos would willfully function in a capacity that is so contrary to the doctors that essentially, he depends on. (Yeah, yeah, I know.)
I digress... as I have already pointed out, much of what I have read over the past several days has left me with a very bitter taste. I have even found myself going to Yahoo message boards to read the history of posts by that seemingly insane Joe_from_Weymouth poster. Though I am pretty sure he posts on iHub, he says much more on the Yahoo board since the posters have a great deal more latitude there. From what I have read thus far, do I think Dr. Ichim, Dr. Min, Dr. Suhy & Benitec have had any idea of what Koos has been up to in his past? Nope. Absolutely not! Do I think Koos's shareholders have been a main concern of his in the past? Nope. Do I think that some of the very bad BMSN/ENTB financial decisions (i.e., Asher/Southridge) that he has made were done out of ignorance? Nope. Do I think that up until very recently there was a whole lot of wool being pulled over our eyes? Yup! Do I think that I am going to sit back and do nothing while I am royally screwed out of my money and treated with an inexplicable disregard? Nope!!!
What that means I don't know just yet. I am working on that one.
That is where I am with this presently as I continue to dig. Try to have a good weekend, most.
One thing I am not concerned with is the treatments; I am not concerned about the time it may take to complete the additional experiments (whatever they may be) or any additional information the FDA has requested the company provide to validate the safety, efficacy & ownership of HemaXellerate. It is still my firm belief that the extent of the present delays go back to the Oregon State mishap as well as the fact that when HemaXellerate emerges finally, it will emerge with Orphan Drug status. I don't believe there will be an additional wait period for this. I believe when approval is at last announced, it will be so with Orphan Drug status.
I absolutely have 100% faith in the medicine and the doctor's creating it. Their reputations, discoveries and work history speak volumes.
When I discovered the major muck up by Oregon State and subsequently alerted the company to it (yes, that was me) judging by the amount of time it took for the USPTO to update the expiration coupled with knowing how the FDA works, I suspected there would be some major changes in the already processed paperwork. Nothing I found indicated that the application consideration would be halted pending these modifications. At least not in terms of evaluating the treatment...not the empirical data, legitimacy, etc., etc., And even after communicating with several lawyers and people in-the-know within pharma & regulations, I still do not know as the consensus is the level of difficulty will be dictated by the person in charge of the case. Protocol or no protocol, much depends on the person whose lap this submission fell in. That is government for you.
My concern now is Koos. To answer a great number of email and PM's: in short, yes, I am pissed, to some extent I feel used and over the past couple of days I have said to myself "what a dumb ass you are!" as I read through file after file after file of information relating to Koos. Yup, I married the science and neglected to thoroughly vet the in-law before doing so.
See, my problem is I have difficulty in wrapping my head around good people being intimately aligned with a POS. Sure, we all have some indirect connection with someone who is absolutely no good. But, as a person who is the antithesis to most things considered commonplace now (i.e., corruption, apathy, laziness, greed, etc., etc.,) I find it very hard to accept that a truly decent person (or people) can be aligned with people (or a person) whose aim is to inflict harm. The moment I figure out that someone who has entered my life is nothing but bad, I do all I can to rid myself of that person. I don't want to be at risk of being personally damaged nor do I want the guilt my association looming over my head. Ridding myself of such is not always an easy task however. So, discovering what I did about the doctors (professionally and personally) it never dawned on me that Koos would willfully function in a capacity that is so contrary to the doctors that essentially, he depends on. (Yeah, yeah, I know.)
I digress... as I have already pointed out, much of what I have read over the past several days has left me with a very bitter taste. I have even found myself going to Yahoo message boards to read the history of posts by that seemingly insane Joe_from_Weymouth poster. Though I am pretty sure he posts on iHub, he says much more on the Yahoo board since the posters have a great deal more latitude there. From what I have read thus far, do I think Dr. Ichim, Dr. Min, Dr. Suhy & Benitec have had any idea of what Koos has been up to in his past? Nope. Absolutely not! Do I think Koos's shareholders have been a main concern of his in the past? Nope. Do I think that some of the very bad BMSN/ENTB financial decisions (i.e., Asher/Southridge) that he has made were done out of ignorance? Nope. Do I think that up until very recently there was a whole lot of wool being pulled over our eyes? Yup! Do I think that I am going to sit back and do nothing while I am royally screwed out of my money and treated with an inexplicable disregard? Nope!!!
What that means I don't know just yet. I am working on that one.
That is where I am with this presently as I continue to dig. Try to have a good weekend, most.
