NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Read closely the words in this Motley Fool articles where disclosure is discussed. I don’t feel like doing any more work than this.

Regardless your research, companies do not have to disclose filing a BLA, acceptance of a BLA, communication with FDA about the BLA, status of the draft label, preprint orders with special service operators, any of the steps along the way really. Approval, or an Approvable letter though…those get disclosed by FDA.

https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/

Often companies have the final draft label minus minor grammatical tweaks well ahead of receiving the approval letter. They already know the answer but it isn’t official and they can’t and don’t leak this information. They can line up contracts and all thing necessary to launch. They can even print material “at risk.” How else do you think product can be available on Monday after receiving the letter on Friday?