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Msg  52716 of 53246  at  1/30/2023 10:55:23 PM  by


 In response to msg 52707 by  Redwood1205
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Re: 2012 Insight

lol. Talk about utter nonsense and massaging data to fit a narrative. Priceless by the clueless one. Drawing definitive conclusions based on a subset of an N that is not statistically significant is laughable and delusional. 
Hey look at the complete remissions that occurred on every single patient who required 7 or 8 surgeries in the previous year, 4 out of 4 CR. That must be the magic numbers. The FDA should approve 2012 immediately for all rrp patients who had 7 or 8 surgeries in the last 12 months. Not 6 surgeries because the treatment did not work for that number of surgeries. I better put a disclaimer for a certain individual who has comprehension issues... WARNING: The above was said in jest.
In all seriousness, below is simply delusional wishful thinking from a frustrated investor who is down 95% on their Intrexon/Prexigen investment.
"The FDA should immediately approve the vaccine for these very severe patients. They not only have very high annual medical costs but the vaccine is dramatically safer than surgeries. On the same front, the vaccine should be approved for those patients wanting to transition from Avastin which is costly and has lower efficacy and major side effects. Obviously the price to these patients could be much higher than currently contemplated"
The FDA will never approve a treatment for a non-life threatening disease based on a statistically insignificant N of 12. You know who also knows this... Precigen, any future partner, Dr Allen, KOL's, analysts covering Precigen, and I am venturing a guess 95% of the readers on this board.   
In Cantor's increased PT note today, even their analyst mentioned "PGEN has said that it will outline its regulatory strategy as its discussions with the FDA advance this year. PRGN-2012's Phase 2 study is enrolling patients, with 32 patients enrolled at Dose Level 2 to date; a question in our minds is whether this can serve as the pivotal trial for PRGN-2012." 
But getting back to Precigen and the FDA. The FDA cannot just approve a drug out of the blue. They require an application to be filed by a company who in this case is Precigen. So instead of throwing a tantrum that 2012 should immediately be approved now, you should get on the phone with Helen and Kirk and plead your case. After Helen is done rolling her eyes, she will immediately dismiss any thought of filing a BLA on 2012 based on a 12 patient phase 1 study. She will not even file a BLA after the phase 2 data unless through her conversations with the FDA she believes that the 37 phase 2 patients is statistically significant enough to receive approval based on the data. Helen will not take a chance of filing a BLA for 2012 if there is a risk the FDA rejects the application and demands Precigen runs a larger size phase 3 trial. This would cause an unwanted delay, not even factoring in the time length of the trial, of possibly 9-12 months 
Dumbdumb, do you know why you are suffering from complications of malaria on the deserted island you inhabit? The entire world except for a few crazies are telling you that you are clueless yet you keep posting on this topic. If Precigen thought there was even the slightest chance of an approval in 3-6 months, they would already be making preparations for commercialization whether they choose to partner or fly solo. If Helen thought Precigen had a chance of approval based on 12 phase 1 data, she would already have clarification from the FDA on the path forward. 
Here is a research project for you... look up how many drugs/treatments the FDA has approved after a n=12 phase 1b on a non-life threatening disease. 

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Msg # Subject Author Recs Date Posted
52719 Re: 2012 Insight Redwood1205 1 1/30/2023 11:44:50 PM

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