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Re: md1225 post# 124044

Wednesday, 06/28/2017 8:48:05 PM

Wednesday, June 28, 2017 8:48:05 PM

Post# of 682063

Look into this trial and timeline to approval. Our Sarcoma DCVax trial will be designed similarly but much fewer patient for quicker results. This is a new FDA, results will be seen very quickly. Within 8 months the company and the FDA will know if accelerated approval is possible imo.


8 months, yeah.

Perhaps they will dose the first patient in 8 months. But I would put 8 years as a more reasonable estimate for approval.

The trial will not be pivitol.

Look at the trial you linked. It used Overall Response Rate as the primary endpoint. The FDA accepts this in a single arm trial, they do not accept OS or PFS. The reason is obvious.

But Direct has yet to show even a single overall response. Makes that endpoint useless.

The trial being launched is another P1/2 level trial. Looking for signs the drug might work. If it shows such, they would launch and actual pivitol trial.

In 16 years this company has not produced results on a single trial. And you expect them to run 2 sequential trials in 8 months.


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