News Focus
News Focus
icon url

hoffmann6383

01/11/23 1:53 PM

#558599 RE: Poor Man - #558598

This is not reflective of what is actually happening with the master file. From the ASM transcript:

So there's a trial master file. And there are case report forms that contain the patient data. There are batch manufacturing records from each individual product that's been manufactured. Overall, the documents could be in the range of 1 million pages. And these pages have to be gone through by humans and they have to be checked and checked for any gaps, inconsistencies, anything so that this body of documents, some of which will go in the application package and some of which will be supportive and have to be inspection-ready, all have to be up to snuff and pass muster with inspection by regulators.

Bullish
Bullish
icon url

Jackxkr

01/11/23 1:53 PM

#558600 RE: Poor Man - #558598

wait till they try and email that file ....
icon url

Horseb4CarT

01/11/23 3:30 PM

#558642 RE: Poor Man - #558598

The Hunt for Blue Cyena