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Re: Question on re-dosing RRPI am going to answer your questions but whether you believe me or anyone else is up to you. That you are even asking these questions should tell you that you should not be investing in biotech companies. A drug that has never been approved by the FDA can never be prescribed even for off label usage in the United States. 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. 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. 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. Precigen understands this and that is why they will 100% run a future trial on redosing. Why... because they want redosing to be part of the label at some point. 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. 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. 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. 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? A redosing trial is not a luxury, it is a necessity for Precigen even if the rate of remission on prgn-2012 in the rrp community stays at 50%. The lower the remission rate, the greater the urgency of running a redosing trial. Another trial that I mentioned Precigen might be required to run is prgn-2012's effectiveness on patients suffering from mild rrp. I would not assume that the FDA is going to give 2012 a broad label on all forms of severity on rrp. This will be significant in terms of revenues per year at severe rrp is seen in approximately 1/3 of the patients. Precigen is running a 4 shot injection treatment given over a 12 week period for severe rrp patients. If Precigen files for a BLA following phase 2 data and the FDA gives approval, the prescribing label is going to look very similar imo. |
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Msg # | Subject | Author | Recs | Date Posted |
52826 | Re: Question on re-dosing RRP | Redwood1205 | 0 | 2/4/2023 2:29:26 PM |