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tulla236a

10/14/20 12:43 PM

#135603 RE: efood125 #135602

i agree it would be wrong to turn it down. it just a new way to administer an already approved drug. it would seem like a slam dunk.

but we have kw in charge.
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DragonBear

10/14/20 1:05 PM

#135607 RE: efood125 #135602

it has previous clinicals behind it-no it doesn't

No FDA sanctioned trials have ever been conducted.

it passed so many tests...



Oh wow. Maybe we should skip CTs on that basis.

the drug involved has already been approved by FDA



Not for use in 2nd line PC. In fact in other past CTs, the use of Ifosfamide for 2nd line PC has failed.

and cell in box causes no immune response...



The goal is not to stick a bead into a person, and the immune system not to respond to it. The goal is to treat the cancer. It has never been shown CIABs are required.

I am still thinking that FDA needs more time to understand how this works and to study the tests and previous clinical results..



The FDA employees are not the equivalent of High School kids requiring months to understand a simplistic antiquated treatment from 20 yrs ago.

30 days seems not enough time and so we have this hold..



So the bottom line is FDA scientists on the review committee need to visit the PMCB site, and watch videos. Along with reading over 200 Kenny PR pumps, in order to understand it as well as SHs?
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A2Z

10/14/20 1:46 PM

#135608 RE: efood125 #135602

They’ve had over 30 days to study it. Sept 2nd when filed today is 14th. That’s 6 weeks. How much time they need.

Something stinks
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mwebb1514

10/14/20 2:27 PM

#135610 RE: efood125 #135602

Especially with COVID being a priority. I agree, very logical.
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thenewmixer

10/14/20 2:59 PM

#135612 RE: efood125 #135602

.I think it will be a disgraceful that this company use PC to fill their pockets