I was hanging my hat on this bit..."The Food and Drug...

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08/11/20

07:43

Post #: 48714334
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Originally posted by onesurfed: ↑

https://www.fda.gov/media/90014/download

A bunch of Q&A in that draft. I'm not one to be schooling anyone, but the way I understand it company will request voucher at the time they file for NDA, which I believe is "New Drug Approval". In order to file for new drug approval, they will have to have completed some clinical trials. Since they're not close to completing trial w/respect to DIPG, filing NDA for Pax is a ways off.
I noted from the Q&A section that PRV can't be used for a drug already approved for some other indication, so they'll have to do the work on DIPG and file NDA for Pax vs. DIPG before they file NDA for Pax vs. GBM (or anything else).

I could certainly be wrong about anything and everything, as it's about 3 a.m. here...

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I was hanging my hat on this bit...

"The Food and Drug Administration (FDA) awards a voucher following approval of a treatment for a neglected disease, rare pediatric disease"

Approval first, followed by receiving a PRV, which can be sold or used towards another drug.

KZA Price at posting: 82.0¢ Sentiment: Hold Disclosure: Held
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I was hanging my hat on this bit..."The Food and Drug...

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