I pointed this out in PM yesterday to a poster over yonder:
" The HemXellerate product is an optimized autologous SVF preparation for stimulation of hematopoiesis that is covered by one issued patent and two patent applications. In practice the physician is shipped a kit, which is used to collect adipose tissue, tissue is sent to a central processing facility, and a standardized cellular product is delivered in a ready-to-use manner. Currently the company is developing various uses for the HemXellerate production in conditions involving suppressed hematopoiesis."
The original link for this is: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543295/
That being said, although "various uses" denotes various treatments and one treatment can be used in various ways, the fact that HemaXellerate I (note the a at the end) is derived from the above mentioned, HemXellerate (no a) suggests that Regen will create multiple treatments from the source. Have I confirmed that there is a HemaXellerate II in the making? As far as my research allows me, yes, I have confirmed that there is a HemaXellerate II in the making. I have said that I believe this to be the case all along. I will not disclose however what I believe that treatment consists of since I have yet to confirm that (disease being treated) beyond a shadow of a doubt.
I have provided several links over yonder to various organizations that outline how the FDA process works. At least two of these were from pharma affiliates that have significant experience in the process. One such link is posted below. I have sifted through my messages and have come to realize that a great many of them, dating back months, have been deleted. In these messages I have noted that the "30 days" is the time period that the FDA must review the application. That means they may very well not look at it until the 30th day. But, as per their own rules, they must at least review it by then for further evaluation.
There are almost always questions by the FDA, especially for smaller biotech's that are not experienced in IND submissions. There is certainly a great chance that additional data will be requested. It is known among large pharma's that the plausibility of further questions and required data exists for them even. That is just the way it goes. This is Regen's first IND application. And application for a treatment that is relatively new as most of us understand. The fact that the application was not immediately rejected OR that trials were quickly initiated then subsequently halted because the FDA found issues, is a great thing. OK, maybe not for those hoping to have seen the pps shoot to the moon after a month. But, for the rest of the world, this is a great thing.
A clinical "hold" or "halt" is the not the same as a FDA Q&A. Regen has been engaged in Q&A. Not a hold.
With respect to the Orphan Drug Status, even since the below link was last updated (I think 2008. Maybe 2009), the FDA has implemented changes to the Orphan Drug Status protocol. These changes were implemented in 2011. And since these changes, more changes have been in the works to better assist companies specializing in cellular medicine since cellular medicine is the new approach in many, many ways and the specialty of smaller companies that do not have the deep pockets that BP have.
Each case is different and the FDA does work case-by-case when required.
Regen has done remarkably well for a little company that has faced a number of unexpected hurdles in the past twelve months or so. And so with sharks and jackals nipping at them every step of the way. That is business, though. The doctors working behind the scenes are not machines and are subject to the same life altering scenarios as you and I. But, they have soldiered on and are doing exactly what they said they would do.
If you are looking to trade this stock and are miffed by the fact the manipulation is not permitting you to make anything more than weekly kool-aid money, that is your fault! Not the company's! Not mine. Nor anyone else's. That is your fault.
Many of us have worked our asses off to provide folk enough information to confirm that this is an investment and that all of the crap that has been said about the company and the science is just that, crap! If you don't like the pace at which this is moving, there are plenty more out there you can flip. Otherwise, consider the amount of time it takes for a life to go from fertilization to emerging into this world a healthy, kicking & squawking life. Then consider that this is medicine aimed at treating diseases that have plagued human life predating history. It takes time!!!
Knowing what I know about the FDA and medicine, my position is now as it has been since my conversation with Dr. Ichim on 17 July: the FDA's decision can come anytime. And I concur with Meach and back up Inventor's latest post...the next PR should not be just about "fluff"...there very well may be a double whammy for us!
BMSN
http://www.pharmatek.com/pdf/PTEKU/Oct012008.pdf
" The HemXellerate product is an optimized autologous SVF preparation for stimulation of hematopoiesis that is covered by one issued patent and two patent applications. In practice the physician is shipped a kit, which is used to collect adipose tissue, tissue is sent to a central processing facility, and a standardized cellular product is delivered in a ready-to-use manner. Currently the company is developing various uses for the HemXellerate production in conditions involving suppressed hematopoiesis."
The original link for this is: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543295/
That being said, although "various uses" denotes various treatments and one treatment can be used in various ways, the fact that HemaXellerate I (note the a at the end) is derived from the above mentioned, HemXellerate (no a) suggests that Regen will create multiple treatments from the source. Have I confirmed that there is a HemaXellerate II in the making? As far as my research allows me, yes, I have confirmed that there is a HemaXellerate II in the making. I have said that I believe this to be the case all along. I will not disclose however what I believe that treatment consists of since I have yet to confirm that (disease being treated) beyond a shadow of a doubt.
I have provided several links over yonder to various organizations that outline how the FDA process works. At least two of these were from pharma affiliates that have significant experience in the process. One such link is posted below. I have sifted through my messages and have come to realize that a great many of them, dating back months, have been deleted. In these messages I have noted that the "30 days" is the time period that the FDA must review the application. That means they may very well not look at it until the 30th day. But, as per their own rules, they must at least review it by then for further evaluation.
There are almost always questions by the FDA, especially for smaller biotech's that are not experienced in IND submissions. There is certainly a great chance that additional data will be requested. It is known among large pharma's that the plausibility of further questions and required data exists for them even. That is just the way it goes. This is Regen's first IND application. And application for a treatment that is relatively new as most of us understand. The fact that the application was not immediately rejected OR that trials were quickly initiated then subsequently halted because the FDA found issues, is a great thing. OK, maybe not for those hoping to have seen the pps shoot to the moon after a month. But, for the rest of the world, this is a great thing.
A clinical "hold" or "halt" is the not the same as a FDA Q&A. Regen has been engaged in Q&A. Not a hold.
With respect to the Orphan Drug Status, even since the below link was last updated (I think 2008. Maybe 2009), the FDA has implemented changes to the Orphan Drug Status protocol. These changes were implemented in 2011. And since these changes, more changes have been in the works to better assist companies specializing in cellular medicine since cellular medicine is the new approach in many, many ways and the specialty of smaller companies that do not have the deep pockets that BP have.
Each case is different and the FDA does work case-by-case when required.
Regen has done remarkably well for a little company that has faced a number of unexpected hurdles in the past twelve months or so. And so with sharks and jackals nipping at them every step of the way. That is business, though. The doctors working behind the scenes are not machines and are subject to the same life altering scenarios as you and I. But, they have soldiered on and are doing exactly what they said they would do.
If you are looking to trade this stock and are miffed by the fact the manipulation is not permitting you to make anything more than weekly kool-aid money, that is your fault! Not the company's! Not mine. Nor anyone else's. That is your fault.
Many of us have worked our asses off to provide folk enough information to confirm that this is an investment and that all of the crap that has been said about the company and the science is just that, crap! If you don't like the pace at which this is moving, there are plenty more out there you can flip. Otherwise, consider the amount of time it takes for a life to go from fertilization to emerging into this world a healthy, kicking & squawking life. Then consider that this is medicine aimed at treating diseases that have plagued human life predating history. It takes time!!!
Knowing what I know about the FDA and medicine, my position is now as it has been since my conversation with Dr. Ichim on 17 July: the FDA's decision can come anytime. And I concur with Meach and back up Inventor's latest post...the next PR should not be just about "fluff"...there very well may be a double whammy for us!
BMSN
http://www.pharmatek.com/pdf/PTEKU/Oct012008.pdf
