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Posted On: 09/01/2020 10:50:45 AM
Post# of 148899
Re: chessmaster #53413
Your responses are somewhat confusing to me.
As mentioned, I am always happy to be corrected, that's how I learn and grow, but let's take a moment and unpack your responses.
You Wrote:
My Response:
I don't understand the distinction you are making. How does a "clock not reset toward the PDUFA date" -- differ from a clock "reset with respect to them responding for a PDUFA date"?
Did you take the time to read the "FDA: CDER 21st Century Review Process" document that I clearly linked in my post?
https://www.fda.gov/media/78941/download
Allow me to provide you with an excerpt from page 20:
You Wrote:
My Response:
If my statement is "absolutely" "FALSE" as you contend, then why does this question need to be asked? You obviously already know the answer, and if you don't, why don't you simply ask the question yourself during the call?
You Wrote:
My Response:
You seem to be saying that you don't know the answer either -- as you want the company to clear up this question on the conference call. So then, you and I are maybe both "uninformed".
You Wrote:
My Response:
I don't know quite how to process this. You seem to be saying that the company will have to "say it", but regardless of what the company says, the clock "wont [be reset] because 2/3rds of the Rolling review are theoretically going on right now so when they get the last submission they have very little left to review."
I think you'd have to agree, there's quite a bit of tension in that statement. You seem to be asserting that it doesn't make a difference what the company says -- the clock will abide by your own understanding of how the universe works.
You Wrote:
My Response:
Since you contend my statement is "absolutely" "FALSE", which is it, are we weeks away or months away? I'm assuming you know the answer to this question.
Also, do you really believe: "I honestly dont think that we will ever find out"? In other words, do you really believe we will never learn this information?
Final Thoughts:
I began my post with this sentence:
"Happy to be corrected, but here is my understanding of the process."
I tend to chose my words carefully, so you can believe me when I said that I was "happy to be corrected".
Like many government agencies, the FDA's regulatory documents can be vague and confusing for laypersons to interpret and comprehend. I've invested time reading more documents than I care to remember in an effort to understand the moving parts of this process -- but I'm not perfect.
I may have possibly included an incorrect data point in my post. And I previewed this very real possibility when I wrote that I would be "happy to be corrected".
I have nothing against you, and I would be happy to be corrected by you. However, your responses don't exactly instill confidence that you know any more than I do.
And if that's the case, you might consider not accusing someone of making an "absolutely" "FALSE" statement unless you can clearly articulate the correct answer.
Again, I am happy to corrected as we all want to know the answer to this question.
As mentioned, I am always happy to be corrected, that's how I learn and grow, but let's take a moment and unpack your responses.
You Wrote:
Quote:
This statement is FALSE without clarification ...
The clock is absolutely not reset toward the PDUFA date because they have a rolling review. Now if you mean reset with respect to them responding for a PDUFA date I will give you that
My Response:
I don't understand the distinction you are making. How does a "clock not reset toward the PDUFA date" -- differ from a clock "reset with respect to them responding for a PDUFA date"?
Did you take the time to read the "FDA: CDER 21st Century Review Process" document that I clearly linked in my post?
https://www.fda.gov/media/78941/download
Allow me to provide you with an excerpt from page 20:
Quote:Please provide clarification.
A refusal-to-file decision ends the review process. The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest. PDUFA V “Program” applications that are subsequently filed over protest are removed from “The Program” and become subject to the standard 6- or 10-month review clock, as applicable.
You Wrote:
Quote:
Now wouldnt this be a HUGE question to ask on the conference call? I hope someone reads this and asks.
My Response:
If my statement is "absolutely" "FALSE" as you contend, then why does this question need to be asked? You obviously already know the answer, and if you don't, why don't you simply ask the question yourself during the call?
You Wrote:
Quote:
This frustrates me that so many are uninformed. The only way to clear this up is to ask the question on the conference call. What impact has the RTF had on the PDUFA date? Will the clock reset to another 6 months.
My Response:
You seem to be saying that you don't know the answer either -- as you want the company to clear up this question on the conference call. So then, you and I are maybe both "uninformed".
You Wrote:
Quote:
They will have to say it could but it wont because 2/3rds of the Rolling review are theoretically going on right now so when they get the last submission they have very little left to review. We are weeks to months away from THE PDUFA date. It will likely be this year but I honestly dont think that we will ever find out because I expect drug approval before then and then HIV can be the label extension.
My Response:
I don't know quite how to process this. You seem to be saying that the company will have to "say it", but regardless of what the company says, the clock "wont [be reset] because 2/3rds of the Rolling review are theoretically going on right now so when they get the last submission they have very little left to review."
I think you'd have to agree, there's quite a bit of tension in that statement. You seem to be asserting that it doesn't make a difference what the company says -- the clock will abide by your own understanding of how the universe works.
You Wrote:
Quote:
We are weeks to months away from THE PDUFA date. It will likely be this year but I honestly dont think that we will ever find out because I expect drug approval before then and then HIV can be the label extension.
My Response:
Since you contend my statement is "absolutely" "FALSE", which is it, are we weeks away or months away? I'm assuming you know the answer to this question.
Also, do you really believe: "I honestly dont think that we will ever find out"? In other words, do you really believe we will never learn this information?
Final Thoughts:
I began my post with this sentence:
"Happy to be corrected, but here is my understanding of the process."
I tend to chose my words carefully, so you can believe me when I said that I was "happy to be corrected".
Like many government agencies, the FDA's regulatory documents can be vague and confusing for laypersons to interpret and comprehend. I've invested time reading more documents than I care to remember in an effort to understand the moving parts of this process -- but I'm not perfect.
I may have possibly included an incorrect data point in my post. And I previewed this very real possibility when I wrote that I would be "happy to be corrected".
I have nothing against you, and I would be happy to be corrected by you. However, your responses don't exactly instill confidence that you know any more than I do.
And if that's the case, you might consider not accusing someone of making an "absolutely" "FALSE" statement unless you can clearly articulate the correct answer.
Again, I am happy to corrected as we all want to know the answer to this question.
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