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flipper44

09/14/21 4:22 PM

#402069 RE: exwannabe #402064

Ex, your insistence that NWBO not wait to release TLD until publication is based upon normal circumstances. These are not normal circumstances. Manufacturing in and of itself is atypical. That alone would cause a rethink of timing, particularly when Dr. Pazdur states new SOCs need to be prepared to ramp for anticipated demand.

GermanCol

09/14/21 4:27 PM

#402071 RE: exwannabe #402064

No, they are not wrong, but for them (usually much bigger companies) there is not as important as it is for a small company like NWBO to have TLD together with the journal publication, so they can get the world to know them, get the word out to the doctors and RA’s and prevent malicious attacks. Also as mentioned by the company, waiting for the TLD announcement doesn’t affect the approval timeline. I think on the other hand, helps getting a faster approval, because of the priority given by the journals when the companies don’t start announcing partíal informaton vía press releases and others, as I shown in my previous post. The faster they have a pier reviewed journal publication, the faster the RA's will consider it for approval.

anders2211

09/15/21 10:08 AM

#402207 RE: exwannabe #402064

Yet, virtually every public company PR's TLD on a material P3 well before the paper



and what is that material event? I will answer my own question Material is when the company has knowledge of results and based on that has high doubt of getting approval as was in the case of CVM. Now tell me why did NWBO not PR TLD yet?