Morning, All:
For those of you that just can't stomach other venues anymore, below is a posting I have provided in response to Veloyt's questions.
I hope it sheds a little bit of light to those of you that still look at the 30 days or with each round of questions it decreases the likelihood of approval and helps you to understand that again, we are dealing with something different from what is considered typical in the world of IND applications.
A: Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
A: Commercial
However, this is not a drug. This is a stem cell therapy treatment . Still very much new in FDA consideration standards. The FDA has yet to write the book on how to regulate the living daylights out of it or what they need to do to make it that much harder on the developer .
Given that it is not a drug, the approach taken by the FDA will be a bit different. The template that has been used for so long to scrutinize, consider and ultimately determine approval or denial for IND applications cannot be used at it has been for so long. This is different and with it carries different risks and benefits that the FDA still are not up-to-date with to some degree.
Therefore, since this is something very much different from what are generally faced with, it was/is going to take them a bit more time to evaluate it and confer to determine if all measures have been taken by the applicant to ensure the process of human trials are conducted as they should be.
Plus, the FDA are slow.
It is kind of like taking in a rescue animal when you already have several, all of which are set in their ways--you quickly learn that although they are all dogs with pretty much the same requirements, you can't quite place the new member in with the others and feel comfortable leaving them alone. You have to take time to understand his/her personality, fears & quirks. And this might take a wee while as you figure exactly what you have to do to really familiarize yourself. Eventually, you have a pretty good understanding of the new addition and unless the new member of the clan turns out to be an aggressor with major issues, he/she will fit right in soon enough and things will move along as they should.
Have I mentioned, too, that the FDA are slow?
With that in mind, understand that since this is not a typical case, the typical turnaround time should not be expected. But, it can be expected anytime and only the FDA knows when.
For those of you that just can't stomach other venues anymore, below is a posting I have provided in response to Veloyt's questions.
I hope it sheds a little bit of light to those of you that still look at the 30 days or with each round of questions it decreases the likelihood of approval and helps you to understand that again, we are dealing with something different from what is considered typical in the world of IND applications.
A: Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
A: Commercial
However, this is not a drug. This is a stem cell therapy treatment . Still very much new in FDA consideration standards. The FDA has yet to write the book on how to regulate the living daylights out of it or what they need to do to make it that much harder on the developer .
Given that it is not a drug, the approach taken by the FDA will be a bit different. The template that has been used for so long to scrutinize, consider and ultimately determine approval or denial for IND applications cannot be used at it has been for so long. This is different and with it carries different risks and benefits that the FDA still are not up-to-date with to some degree.
Therefore, since this is something very much different from what are generally faced with, it was/is going to take them a bit more time to evaluate it and confer to determine if all measures have been taken by the applicant to ensure the process of human trials are conducted as they should be.
Plus, the FDA are slow.
It is kind of like taking in a rescue animal when you already have several, all of which are set in their ways--you quickly learn that although they are all dogs with pretty much the same requirements, you can't quite place the new member in with the others and feel comfortable leaving them alone. You have to take time to understand his/her personality, fears & quirks. And this might take a wee while as you figure exactly what you have to do to really familiarize yourself. Eventually, you have a pretty good understanding of the new addition and unless the new member of the clan turns out to be an aggressor with major issues, he/she will fit right in soon enough and things will move along as they should.
Have I mentioned, too, that the FDA are slow?
With that in mind, understand that since this is not a typical case, the typical turnaround time should not be expected. But, it can be expected anytime and only the FDA knows when.
