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Re: Question on re-dosing RRPMabel You are as usual misrepresenting my points and/or stating things that everyone knows. A drug that has never been approved by the FDA can never be prescribed even for off label usage in the United States. Of Course The protocols of dosing in a trial which subsequently receives FDA approval are highly correlative to what appears on the label. This is why I mentioned in a post recently the importance and risks of the label. The trial dosing protocols and the data determines the prescribing label. Of course but then it can be prescribed off label including re-dosing. In order for Precigen to have redosing on its label, they are going to have to run a phase trial that incorporates redosing to prove safety and efficacy. Just because prgn-2012 has shown itself to be extremely safe on 4 injections does it mean they will assume that it is safe for 12 injections. Nor will they assume that redosing will elicit equal or superior response/efficacy compared to the first treatment. Of course Whether you want to believe it or not, 2012 has a durability issue with some percentage of patients that redosing might be able to address. The ability to re-dose has been MY point all along. Precigen understands this and that is why they will 100% run a future trial on redosing. Of course Why... because they want redosing to be part of the label at some point. Of course but I am trying to explore nearer term options for deployment. Insurance companies are not going to pick up coverage on off label redosing when they have zero data to back up whether it provides any benefit. Drugs do not have revenues of 300M/yr from off label usage. I think a number probably do but I am not an expert. Quick google search says 10 to 20% of prescriptions are off label/ Pricing also becomes an issue. If Precigen prices their 4 shot treatment at 200k dollars, do you really believe that a doctor is going to prescribe the $200k treatment again off label when the first treatment worked for less than a year and they have no data to suggest that redosing the treatment will deliver any better results? No chance. Even if Precigen rebates 50% on redosing, how many patients are going to pay 100k out of pocket on a treatment that just showed an effectiveness for 6-9 months? Not many imo and certainly not enough that it will drive significant revenues for Precigen. You seem to have no creative thinking what so ever. How about including free re-dosing option in the initial $300,000 price. Kind of like a warranty. The reason that Avastin is sometimes prescribed off label is because systemic avastin has shown it is highly effective at reducing papilloma growth as long as a patient stays on the treatment. I There have been published reports about avastin even though a trial has never been run but the benefits of Avastin in terms of helping reduce papilloma has taken a long time to gain traction. When will published reports about 2012 redosing be available if a study by Precigen does not occur, 1,3, or 5+ years? Do you even think about what you are saying. Avastin has NO durability, not even a trial to support it's use, is extremely expensive, has severe side effects for many, and has to be repeatedly re-dosed off label in all respects.
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Msg # | Subject | Author | Recs | Date Posted |
52828 | Re: Question on re-dosing RRP | Mabel | 0 | 2/4/2023 3:51:40 PM |