Replies to post #134995 on PharmaCyte Biotech Inc (PMCB)

[A2Z]

Wrong. Sorry. FDA wants more test that couldn’t be accomplished in the 3 weeks left and your genius didn’t have the cahonies to come out and tell SH ... don’t spin it. Admit it.

[otto17]

and Drug Master File has been accepted
FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy

[fraum]

As soon as possible, and no more than 30 days after imposition of the clinical hold, a written explanation of the basis for the hold will be issued by FDA

As soon as possible. That is when the FDA will tell pmcb whats wrong. The FDA is not PMCB so it is highly unlikely they will take a month to inform pmcb why the hold was placed. Id be surprised though if KW doesnt wait the full month before telling SH whats up if he ever does.

Good thing they waited eight years to get it "PERFECT" Lolololol!!!!

[DragonBear]

the fda learned quite a bit about cell in box and wants to learn more...

There's really nothing complicated to learn. It's quite simplistic. And no, the FDA does not place an IND on Hold because they want to learn more. There were deficiencies in the IND. The FDA's mandate is not to "learn" from Kenny.

seems they are not questioning the use of the drug involved here as that drug is already FDA approved for use..

Not even close.

The only FDA approval for Ifosfamide is:

IFEX is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.

It's used in 10 other cancers - off label. None of em being solid tumor cancers.

One of the reasons for a Hold is if there are questions about the efficacy of the drug for the treatment proposed. There's more than one past CT showing Ifosfamide had a lack of efficacy for 2nd line PC patients. That could be a show stopper for even a Phase 1 CT. Much less a Phase 2b dream.

and besides cell in box will require only 1/3 the normal dosage so that should be a plus in eyes of fda

No, that's not a plus, because there's nothing unusual about it. A dose at 1.0 gms/m2 isn't that much different than the recommended dose of 1.2 gms/m2 for germ cell testicular cancer. Then factor in Glufosfamide in a Phase 3 CT for PC. Where with 1/4 the toxicity of Ifosfamide, one can administer 4X more of Glufosfamide. Or 4.5 gms/m2 equating to the same toxicity of Ifosfamide at 1.1 gms/m2. Yes, 4X more drug administered is a plus for Glufosfamide, relative to Ifosfamide.

There's no reason to believe the FDA isn't questioning Ifosfamide. Also note for the one approved use, it's not as a monotherapy drug, but in combination with other drugs.