(In response to bioboy)
You said: "First of all, I hope you understand what approval rate looks like in the entire biotech/ pharma space and the years of trials needed plus the $$ required to get approval even before a treatment can go to market."
I believe I was pretty clear about my understanding of the duration and $$$ required for trials. Particularly for smaller biotechs. Hence the mentioning of BP (that would be big Pharma) funding trials. [/color]
You said: "Secondly, do you know any company that received FDA approval with most of their trial subjects dead during P1 or P2? How will any company prove their treatment works if subjects do not live long enough to finish the study? Let's say for a minute that HemaXellerate showed positive response after 6 months in most of its subjects then in subsequent months, those subjects all passed. BMSN will meet its primary endpoint at 6 months of P1 but what would the secondary endpoint look like? Are they going to keep repeating P1 or do P1a, P1b and so on? How will BMSN ever prove their treatment works? Is it important that a treatment shows positive response or should it promote overall survival or good median survival? If treatment response is positive, why are patients dying and how do we eliminate positive response or death as an event that is or is not occurring randomly (chance) if we have a small study size like 10?"
I don't think you are understanding the concept of utilizing exogenous cells as a means of accelerating recovery. And until you do, you cannot understand how profoundly flawed your P1/P2 time issue argument is. Further to that, it is obvious that you do not understand how trials really work and what factors are considered from beginning to end. ---- To quote the FDA : "Our action will depend on the characteristics of the adverse events, the frequency of the reports, the seriousness of the diseases or conditions for which the drug provides a benefit, the availability of alternative therapy , and the consequences of not treating the disease. Detection and limiting adverse reactions can be challenging. Weighing the impact of adverse drug reactions against the benefits of a particular product is multifaceted and complex, and involves scientific as well as public health issues. ---
The science that HemaXellerate is derived from has been closely studied since the 1970's. And it is a treatment option that is long overdue in a world where 7.6 million people die of some form of cancer every year.
(Again, until you truly educate yourself on the above mentioned, I could go on until The Calling and it will do little, if any, good.)
You said: "I highly suggest you check with people in the medical /science field and get another opinion on this view. They will confirm and support my view without calling me names."
I AM in the field.
I can't bring myself to respond to the last bit of your message due to how ludicrous it is--you scoff and attempt to dissect, seemingly being an educated opponent, when in reality you know very little about any of it. I suggest you thoroughly research how pharma works and perhaps familiarize yourself with "data mining", how often BP infiltrates everywhere from hospitals to medical schools , and monetary persuasion. In this business, you only release what you absolutely have to. And oft times what is released is cloaked.
The biggest challenge Hema faces is that in an industry that is expected to reach 1.1 trillion in sales by next year, BP might have some problems with a treatment that may actually reduce the need for long term prescription drug needs. Depends on what price tag can be attached to the therapy (and believe you me, they are doing the math on this). We are talking about an industry whereby for every dollar spent on research, nineteen dollars is spent on promotions and advertising. No, am not kidding. That is the biggest challenge for HEMA. But let a BP determine that this treatment is in their best interest, and the sky is the limit.
Why are you on this board if there is no benefit to you?
BMSN
You said: "First of all, I hope you understand what approval rate looks like in the entire biotech/ pharma space and the years of trials needed plus the $$ required to get approval even before a treatment can go to market."
I believe I was pretty clear about my understanding of the duration and $$$ required for trials. Particularly for smaller biotechs. Hence the mentioning of BP (that would be big Pharma) funding trials. [/color]
You said: "Secondly, do you know any company that received FDA approval with most of their trial subjects dead during P1 or P2? How will any company prove their treatment works if subjects do not live long enough to finish the study? Let's say for a minute that HemaXellerate showed positive response after 6 months in most of its subjects then in subsequent months, those subjects all passed. BMSN will meet its primary endpoint at 6 months of P1 but what would the secondary endpoint look like? Are they going to keep repeating P1 or do P1a, P1b and so on? How will BMSN ever prove their treatment works? Is it important that a treatment shows positive response or should it promote overall survival or good median survival? If treatment response is positive, why are patients dying and how do we eliminate positive response or death as an event that is or is not occurring randomly (chance) if we have a small study size like 10?"
I don't think you are understanding the concept of utilizing exogenous cells as a means of accelerating recovery. And until you do, you cannot understand how profoundly flawed your P1/P2 time issue argument is. Further to that, it is obvious that you do not understand how trials really work and what factors are considered from beginning to end. ---- To quote the FDA : "Our action will depend on the characteristics of the adverse events, the frequency of the reports, the seriousness of the diseases or conditions for which the drug provides a benefit, the availability of alternative therapy , and the consequences of not treating the disease. Detection and limiting adverse reactions can be challenging. Weighing the impact of adverse drug reactions against the benefits of a particular product is multifaceted and complex, and involves scientific as well as public health issues. ---
The science that HemaXellerate is derived from has been closely studied since the 1970's. And it is a treatment option that is long overdue in a world where 7.6 million people die of some form of cancer every year.
(Again, until you truly educate yourself on the above mentioned, I could go on until The Calling and it will do little, if any, good.)
You said: "I highly suggest you check with people in the medical /science field and get another opinion on this view. They will confirm and support my view without calling me names."
I AM in the field.
I can't bring myself to respond to the last bit of your message due to how ludicrous it is--you scoff and attempt to dissect, seemingly being an educated opponent, when in reality you know very little about any of it. I suggest you thoroughly research how pharma works and perhaps familiarize yourself with "data mining", how often BP infiltrates everywhere from hospitals to medical schools , and monetary persuasion. In this business, you only release what you absolutely have to. And oft times what is released is cloaked.
The biggest challenge Hema faces is that in an industry that is expected to reach 1.1 trillion in sales by next year, BP might have some problems with a treatment that may actually reduce the need for long term prescription drug needs. Depends on what price tag can be attached to the therapy (and believe you me, they are doing the math on this). We are talking about an industry whereby for every dollar spent on research, nineteen dollars is spent on promotions and advertising. No, am not kidding. That is the biggest challenge for HEMA. But let a BP determine that this treatment is in their best interest, and the sky is the limit.
Why are you on this board if there is no benefit to you?
BMSN
