NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Was compelled to say a few words, maybe from drinking too much coffee this morning:

Avastin was approved by FDA in 2017 for rGBM patients for not improving OS but increased time to disease progression or death by about 2.7 months; [note it failed its primary endpoint of OS]

The current SOC for nGBM has not improved patient survivals for at least over a decade;

FDA approved Optune device for both n in 2015 and rGBM in 2011 has been controversial, but it doesn't prevent it from becoming a blockbuster treatment with market cap of about $19.5 billion today;

A great number of small developing stage biotech companies have seen their stock prices increased two to ten fold today from years of stalled prices in today's peculiar investment environment, despite many of these companies having no fundamental values at all but just stalled the price for a long time;

The 2018 JTM published DCVax-L data demonstrates both safety and efficacy of DCVax-L in treating nGBM. The following up data reveals an improved treatment trend;

The revised and reordered endpoints contained in the same revised SAP submitted to four RAs indicate the RAs have followed through with their understanding and updated guidance on the basis of the immunotherapy as a new class of cancer treatments which requires appropriate measurements for respective treatment efficiencies which are delayed but sustaining in nature;

From an educated guess and reasonable data analysis, the Phase 3 DCVax-L trial, datalocked as of 5 October, will be readily significant in meeting its primary endpoint, hence the investment in NWBO stock is no longer faced with a binary event.

And it can also be concluded from the above that it's highly likely the company has also been in negotiation with RAs for the approval of DCVax-L for rGBM besides the initial planned nGBM.

Since DCVax is a platform treatment for all solid tumors, if the price of DCVax-L for GMB indication is $10, then the price of NWBO by considering other indications shall readily reach multiple fold of the $10 as long as the concept of DCVax-L is approved.

Then, there will be the huge potential of DCVax-D coming into play.

The day of concept-of-approval unveiling DCVax-L trial data is quickly approaching!