OK, I have had a chance to review questions I have received here and elsewhere. Since I am presently lacking the brain power required to even look at the board "elsewhere" right now, I am going to try to offer what I hope to be a clarification that makes sense and allays concerns of some. I will start by pasting a PM response to a very much invested BMSN buyer:
They did not resubmit the application. They received questions from the FDA and answered those questions. They then received a request for more data on the efficacy. They submitted this data sometime between receipt of the request (28 June) and 17 July when I spoke to Dr. Ichim and he confirmed that they had submitted the required information to the FDA for the SECOND round of questions. We do not know when the data was submitted OR if the FDA had already established with Regen during the course of the first Q&A if they, Regen, are required to WAIT for additional responses or could proceed with trials if nothing after 30 days.
You are missing key points here: there was a second round of questions to which data was supplied sometime after 28 June and before 17 July. Since the data provided required 14 days to confirm the determination one HAS to assume a new study was conducted since Koos was specific when he indicated data was GENERATED.
Key point #2: WE DO NOT KNOW IF THERE WAS A PROVISO established during part 1 of Q&A that dictated that Regen MUST wait for confirmation from the FDA after they have received/reviewed the responses to their questions.
I do not wish to seem bitchy, but fact is we do not know when we should expect a definitive response from Regen. Now, most of us are proficient enough with math that we can count back and speculate. But only Regen knows if they in fact were slapped with a proviso and if they received confirmation by the FDA that they have the FDA's blessing to move forward on Friday. Or, if they will receive it tomorrow.
If a proviso was not established, then most of us know enough based on the dd provided in the recent past that initiation of trials can start anytime if we consider that the "generated" dated was most likely submitted somewhere around 5 July (basing this on the 14 day time period required to generate the requested data.
Again, I appeal to you that you understand that we are not dealing with gold digging holding companies or yacht fleets. We are contending with the FDA and a protocol that is so convoluted and so extensive that if you spent every moment of every evening trying to familiarize yourself with the psychology or keep abreast of the constant changes, you would eventually find yourself running naked down the street screaming incoherently some twisted nursery rhyme from your youth!
This is not a get rich quick scheme. There is so much that the general public does not know. Nor will they ever know. What you should take comfort in however is the fact that you are invested in a company that although they have not been communication friendly with the masses (and that especially includes those of us that have financed their endeavors) they have been as transparent as any company can be from a legal standpoint and that they are quite literally creating , not attempting to create mind you, but creating cures for various types of CANCER!
They did not resubmit the application. They received questions from the FDA and answered those questions. They then received a request for more data on the efficacy. They submitted this data sometime between receipt of the request (28 June) and 17 July when I spoke to Dr. Ichim and he confirmed that they had submitted the required information to the FDA for the SECOND round of questions. We do not know when the data was submitted OR if the FDA had already established with Regen during the course of the first Q&A if they, Regen, are required to WAIT for additional responses or could proceed with trials if nothing after 30 days.
You are missing key points here: there was a second round of questions to which data was supplied sometime after 28 June and before 17 July. Since the data provided required 14 days to confirm the determination one HAS to assume a new study was conducted since Koos was specific when he indicated data was GENERATED.
Key point #2: WE DO NOT KNOW IF THERE WAS A PROVISO established during part 1 of Q&A that dictated that Regen MUST wait for confirmation from the FDA after they have received/reviewed the responses to their questions.
I do not wish to seem bitchy, but fact is we do not know when we should expect a definitive response from Regen. Now, most of us are proficient enough with math that we can count back and speculate. But only Regen knows if they in fact were slapped with a proviso and if they received confirmation by the FDA that they have the FDA's blessing to move forward on Friday. Or, if they will receive it tomorrow.
If a proviso was not established, then most of us know enough based on the dd provided in the recent past that initiation of trials can start anytime if we consider that the "generated" dated was most likely submitted somewhere around 5 July (basing this on the 14 day time period required to generate the requested data.
Again, I appeal to you that you understand that we are not dealing with gold digging holding companies or yacht fleets. We are contending with the FDA and a protocol that is so convoluted and so extensive that if you spent every moment of every evening trying to familiarize yourself with the psychology or keep abreast of the constant changes, you would eventually find yourself running naked down the street screaming incoherently some twisted nursery rhyme from your youth!
This is not a get rich quick scheme. There is so much that the general public does not know. Nor will they ever know. What you should take comfort in however is the fact that you are invested in a company that although they have not been communication friendly with the masses (and that especially includes those of us that have financed their endeavors) they have been as transparent as any company can be from a legal standpoint and that they are quite literally creating , not attempting to create mind you, but creating cures for various types of CANCER!
