News Focus
News Focus
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biosectinvestor

04/14/24 1:27 PM

#685143 RE: meirluc #685139

A long time ago I dug deep into pre-approval manufacturing gearing up to commercialization. It was my conclusion back then that regulators make a special effort before approval to make the new technologies companies understandably implement prior to approval, gearing up for approval, easier to get approved. Further, having the ability to potentially meet demand and create a treatment that is validly not just efficacious but deliverable, is a consideration for the regulators.

So at that time it was my conclusion that they would likely delay until they had gotten their commercialization and specifically their manufacturing technologies to a certain point in the regulatory process before applying to any regulator.

I am sure they would have loved to have had more availability for patients sooner. But there is only so much that can be done at any given time. The obvious solution has always been to have many more resources but the objective of all of the shorting has always been to keep them short on resources and maximize dilution. In that context, the shorts have been successful. But shorts cannot change the technology.
Bullish
Bullish
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hyperopia

04/15/24 10:40 AM

#685235 RE: meirluc #685139

meirluc, Northwest Bio has always said they want this treatment available to everyone, not only those that insurance is willing to pay a high price for, so that requires automated manufacturing. Along with the Flaskworks automated manufacturing process, Northwest Bio (Advent) has also been automating final product testing methods (assays), for a completely digital manufacturing and release process that will allow a much more rapid batch verification and final product release. I believe this may be all tied together, so there may not be an interim step to manufacture commercially using the manual method for a few months, and then switch over, and then negotiate a different price based on a different manufacturing method.

As far as the timing of everything, I’m just speculating as I see it, and could be wrong, so we will have to see how it plays out. I do think many investors here don’t fully understand or appreciate how difficult it is for a small company like Northwest Bio to bring a novel cell therapy treatment to market, and be required to pioneer and orchestrate so many moving parts, especially with contractors and backlogged regulators. It’s far easier to sit in the back seat (with a very limited view) and point fingers at the wouldas and couldas along the way. (I’m not saying that you’re doing this meirluc)

I keep hearing this same line repeated - that all these cancer patients are dying because it is taking so long to bring this treatment to market, and somehow, that is seen as Northwest Bio’s fault. Let’s get something straight: The length of time it has taken is not all Northwest Bio’s fault. And neither is all the dilution that resulted from the short attack, and being forced to raise capital at prices well below $1, with warrants and other unfavorable terms attached.

Remember that Northwest Bio was on track with multiple clinical trials for both DCVax-L and Direct, attending investor conferences, trading on the Nasdaq, receiving investment from institutional investors, before it was attacked, frivolous lawsuits brought against them, and a false narrative created and spread, to make to appear as if “DCVax doesn’t work, the phase III trial failed, and management is misleading investors.”

The fact is, that Northwest Bio’s stock had risen rapidly to a high of over $12 which gained the attention of nefarious hedge funds, who saw an opportunity to make some easy, risk-free money. They hired someone to write a false “research report” as a basis for them to perpetrate a short and distort attack on the stock. These hedge funds are the ones responsible for starving Northwest Bio of the necessary resources required to bring DCVax to market in a timely manner, and depriving cancer patients of this treatment.

Linda Powers and Northwest Bio have survived the attack and overcome numerous hurdles in their path to bringing this novel cell therapy to the commercial market. They have almost solved the major bottlenecks that would prevent the large scale manufacturing and mass distribution of this cell therapy, and are now finally on the verge of regulatory approval. I have full confidence that when the time comes for commercial manufacturing, the best choice will be made, whatever that is.