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Zadie420

10/15/22 7:22 AM

#522063 RE: CherryTree1 #522062

100% agree. Keep in mind once the combination trial results show significant OS then the other pharma at other end will try to use the same combination for other cancers. This is the least path of resistance.

I wish someone would have helped NWBO with DCvax- D for phase LL and with good results expands to phase lll.


This is my only post of the day.
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Maverick0408

10/15/22 7:24 AM

#522064 RE: CherryTree1 #522062

Just read that document carefully and you will understand why!
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eagle8

10/15/22 11:27 AM

#522088 RE: CherryTree1 #522062

Thank you CherryTree1.
For showing some proof.
DCvax will be used for different tumors in the near future.
imo,

GLTU
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exwannabe

10/15/22 11:55 AM

#522093 RE: CherryTree1 #522062

The off-label use would be minimal if it does get approved.

First, the definition of the approved product will include the source of the lysate, and that will be the patients' glioblastoma tumor (maybe plus wIDH). If it is manufactured with a different tumor material, it is not the same product. Thus it is not off-label, but unapproved.

Second,, insurance and risk is a huge real world issue. That is why Specials does so little despite not being capacity constrained.

Not that we will ever know the answer.
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Chiugray

10/16/22 9:24 PM

#522397 RE: CherryTree1 #522062

Cherry,
Thanks for the information on off-label use for approved drugs. I’ve always believed DCVax will not only work across multiple cancers but also for early-stage tumors as well. Off-label can be a path. Given DCVax-L will almost certainly be approved for GBM (grade 4) brain tumors and in fact become standard of care quickly, these same oncologists will most likely recommend it for lower grade brain tumors (grades 1, 2, 3) as well.

Even grade 2 brain tumors are described as “likely to come back after treatment” and grade 3 as “rapidly dividing cells.” So, I think not just oncologists but these patients will also demand DCVax as a prophylactic (preventative) vaccine, given its efficacy and non-toxic profile.

It also offers the hope for “cure” and a peace of mind. Results showing a 2X increase in long tail survival for GBM implies not only strong efficacy but that a long-term immune memory is created to protect against recurrence.

Maybe this new DCVax paradigm of a personalized, single batch mfg for multi-year treatments means we also get a new drug pricing paradigm, a pay-as-you go pricing. Align the incentives. Doctor/patient will continue to use it as long as it continues to work. And as long as it works, healthcare insurance companies saves money on prevention.

Strawman pricing model
- Yr 0: Upfront mfg (fully loaded cost), $40K
- Yr 1: Primary 7 injections, $70K
- Yr 2: booster 2 injections, $20K
- Yr 3: booster 2 injections, $20K
Total Price, average: $150K (US price $200K, EU price $100K)
Gross margin: 73% (MRK 70%, BMY 79%, Roche 68%)
Assuming 11 injections over 3 years: $10K per injection