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Re: P3 Trials & Partership???...alf more and Fall fall my nuance was word track alf , you replied >The latest excuse proffered by Money
appears to be related to wanting to include all RA treatment patients
not just one specified treatment. Somehow, this is seen as some type of
genius strategic move?? First, this seems like a complete
no-brainer and makes you wonder why anyone would have ever thought
looking at just one type of treatment was a good idea. If you have a
marker aimed and determining if RA is responding to treatment....It's just numbers not methodology we are talking about.< Not sure what you are pointing out is a no brainier or is just numbers, but I am not pointing out 2 arms. I am hypothesizing about the method (regardless of term used) is putting all comers into 2 different imaging buckets/tracks under the accelerated/expedited program for serious conditions. So, again anti-TNFa in one imaging bucket/track (or whatever one titles it,) going all the way thru to NDA and "other therapeutics" in another imaging bucket/track with intermediate endpoints, that does not have to go all the way thru to end point for an NDA if anti-TNFa works, but if if meets intermediate endpoint like big pharmas do in serious conditions can fill an NDA at meeting intermittent, or at a minimum can start into P3, Is this simple minded or a stroke of out of the box thinking/genius as usually reserved for big pharma below, so in my words "Wonder whose idea two tracks was, but is very big
strategic/tactical arrangement" or will accept your word genius for whomever thought of it, if FDA approves Background for my precept of P3 in different buckets is more than arms, but tracks for serious conditions Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’"... The second method for approval is accelerated approval.
Accelerated approval is reserved for drugs that relate to serious
conditions and life-threatening illnesses without cures. The process
cuts the time it takes for a drug to become available." Excerpts from the FDA program to give more rapid access
to new drugs/diagnostics: termed accelerated or expedited programs for serious conditions Accelerated Approval Program The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval..... B. Accelerated Approval Endpoints The two types of endpoints that can be used as a basis for accelerated approval are: (1)
a surrogate endpoint that is considered reasonably likely to predict
clinical benefit and (2) a clinical endpoint that can be measured
earlier than IMM that is reasonably likely to predict an effect on IMM
or other clinical benefit (also see section VII.D.2.). For purposes of this guidance, these categories of endpoints are referred to as surrogate endpoints and intermediate clinical endpoints, respectively. Intermediate Clinical Endpoints For purposes of accelerated approval, an intermediate clinical endpoint is a measurement of a therapeutic effect that can be measured earlier than an effect on IMM and is considered reasonably likely to predict the drug’s effect on IMM or other clinical benefit. An important question is whether the demonstrated therapeutic effect alone would be a basis for traditional approval. Approvals for products for serious conditions based on clinical endpoints other than IMM will usually be considered under traditional approval procedures. Approvals based on such clinical endpoints will be considered under the accelerated approval pathway only when it is essential to determine effects on IMM or other clinical benefit in order to confirm the predicted clinical benefit that led to approval. Although FDA has limited experience with accelerated approvals based on intermediate clinical endpoints, FDA believes intermediate clinical endpoints generally could be used to support accelerated approval in situations such as: A study demonstrates a relatively short-term clinical benefit in a chronic disease setting in which assessing durability of the clinical benefit is essential for traditional approval, but the short-term benefit is considered reasonably likely to predict long-term benefit. A clinical endpoint demonstrates a clinical benefit that is reasonably likely to predict an effect on IMM in a disease setting in which it is essential to confirm the effect on IMM (e.g., because available therapy has established effects on IMM). |
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Msg # | Subject | Author | Recs | Date Posted |
35225 | Re: P3 Trials & Partership???...alf more and Fall | Fall1980 | 2 | 10/24/2021 3:56:16 PM |