Replies to post #244777 on Biotech Values

[Margin Buu]

A Phase 1 study with thirty-eight patients is not a valid comparison to NW's Phase 3 results.

[flipper44]

While anyone here should agree not all risk is eliminated from the approval process for DCVax-l, the Omburtumab rejection comparison you found for is well off the mark.

For starters, regarding Omburtamab, the agency said that it could not be ascertained that the patients in the external control group selected for reference by the company, had a similar underlying prognosis as those treated with Omblastys in the study.

Whereas, GBM has an extremely well understood underlying prognosis.

That’s just one point. There are so many more factors beyond just that boding well for the DCVax-l data. Have a nice Friday evening.

[kabunushi]

For 131I-omburtamab, Serious Adverse Events (“SAE”) was found in 40.6% of the patients and were mostly related to myelosuppression.

[Doc logic]

DewDiligence,

This trial example you present did not keep out 17 SOC/placebo patients from enrolling while all the planned for treatment arm continued on to full enrollment. This obvious green light for the L treatment is seen in the data released and Fraunhofer’s claim the the trial was only enrolled to the point statistically necessary.
The company was not ready with commercial manufacturing in 2015 and the environment for recognizing treatment induced pseudoprogression as a marker for treatment effect and OS improvement needed to be determined over a longer period of time. This made an earlier approval impossible and access to this treatment had no viable pathway for a company that could not afford to give this treatment away because it wasn’t a cheap to make pill and NWBO had no good source of income from other products.
Bottom line, when a product truly proves itself over time (actual heartbeats) and the company waits out “the process” and gets recognition by a top journal as legit, regulators have no reason not to approve and every reason to approve. This example you provide does not come close to an equivalent comparison. Best wishes.