Replies to post #771245 on NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

And the list is even longer than that of biotechs that go down after approval. Autolus and Adaptimmune are two examples in the cell therapy space aside from Iovance, so Iovance is not really alone in this environment.

Just yesterday, Nuvation Bio got an approval for what looks like a best-in-class ROS1 inhibitor in NSCLC. So this phenomenon is not even limited to cell therapies.

Next up (decision deadline tomorrow) is UroGen, but their stock is down right now because the ODAC was split on recommending approval, so they might actually go up if the decision is positive.

[kabunushi]

Do you think that the market has already discounted any risk of MAA not being approved, i.e. the current pps doesn't reflect any discount due to the MAA final status being unknown as yet?

[kabunushi]

This is more or less the opposite of what you wrote (below) 3 weeks ago. What has caused you to change your mind drastically?

I find it incredibly odd that you think the stock price would hardly move IF there is MHRA approval.
We are 17 months after MAA has been submitted, which is very worrisome. IF approval is announced, the market will be overwhelmed with joy and buy the crape out of nwbo stock. Now the market is 50/50 on approval. Im at 60/40 tbh. The market is by far NOT taking approval in account as a given.

[brooktrail1933]

Some folks are quite confident the company has a partner with up-front cash. And the partner may not be the one everyone assumes. We will see.

[antihama]

DD, your point

regarding Iovance Biotherapeutics with FDA-approved lifileucel (to treat adult patients with unresectable or metastatic melanoma) in February 2024. Market cap $ 750 million now thats 80% down since FDA approval

is an interesting one and I was wondering how that would compare to NWBO and DCVax-L. There are a lot of things to look at in making a comparison (MC, SP suppression, regulatory markets, pipeline, etc) but a big biggie in my book that DCVax-L has in its favor that would help maintain its SP is competition within its drug class which translates into revenue. DCVax-L in GBM would have no competition, it would be the go to drug to treat GBM. Lifileucel, on the other hand, in unresectable or metastatic melanoma (and looking at the FDA approval PR, it's a subset of that) has a ton more competition as well as a much smaller # of potential patients (when comparing GBM in United Kingdom vs a subset of metastatic/unresectable melanoma in the US). Looking at the NCCN Guidelines, for 2nd line melanoma, Lifileucel is 1 of 7 preferred treatment options and then there is an additional 11 non-preferred options. That’s a lot of competition in a smaller selective metastatic/ unresectable melanoma market vs DCVax-L in go to first in class glioma. Revenue talks!