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biosectinvestor

09/20/20 7:22 PM

#309396 RE: exwannabe #309395

You know why. Some of these are trick questions.

Originally you implied that the SAP was an SPA to create ambiguity and confusion. When I called you out on it, a long time ago, you pretended it never happened. The approval process for an SPA is much like and IND, you submit it until there are no more comments over a period of time, and then, you may proceed.

As for any ambiguity on time lines, they indicate at each step that events are advancing. They do not have a requirement to announce and at some point it is reasonable to go quiet. Additionally, it leaves shorts in the dark to some degree, which is likely a good strategy.

Enjoy the ambiguity.

MI Dendream

09/20/20 9:07 PM

#309413 RE: exwannabe #309395

All site databases were locked as of July 24. That means these already went through QC. The amount of data to be added is minute compared to the truckloads of data coming from the sites.

The data is in hand and probably has been for a week or more.

Folks...we have a winner!!!!

anders2211

09/21/20 8:50 AM

#309455 RE: exwannabe #309395

Why would the announce the SAP is mostly complete. The draft is complete. But never announce it was submitted an accepted as an IND change?



This has been my concern as well for a long time. It would be of the utmost outrages misleading calculated behavior from the part of NWBO management to subject a BLA filing without approved change IND. I cant imagine NWBO management would dare such a stupid gamble not to mention misleading everyone and anyone.

The whole leaving shorts in the dark is, given the surprisingly open communication of NWBO the last months non sequitur.