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biosectinvestor

12/31/22 8:03 PM

#555076 RE: Horseb4CarT #555072

Agreed Hb4C, people need to be patient. The company has not even applied yet. The FDA is going to do their job and antagonizing them or casting aspersions before things start is really what shorts and AF would love to see. It's the absolute worst way to wish for success.
Bullish
Bullish
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skitahoe

12/31/22 9:01 PM

#555082 RE: Horseb4CarT #555072

We're in agreement, but I believe the FDA knows the difference between criticism coming from investors, and criticism directly from the company. In the case of DNDN, I'm not certain that the FDA didn't think the company was behind the efforts of the investors to rattle the cage.

I don't believe the company is in any way encouraging investors to be critical of the FDA or other regulators, I believe they have good repore with all the regulators. Personally I've always thought the FDA could be more dynamic and I've been open about saying it. I have never advocated trying to go over their heads to make things happen.

When we look at 2022 it certainly failed to meet our expectations. My survey that had 80+ investors by the time it was finished had an average of about $25 for the year end price, clearly we fell far short. On the other hand 2022 was one of the worst market years in several years. Year end we were up roughly 12% on the year, I'd guess that almost every investor I know in the market would have been thrilled by 12% gains in the last year.

Let's hope that 2023 lives up to the expectations we had for 2022, or even comes close to it.

Happiest and Healthiest of New Year's,

Gary
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Basilisk

12/31/22 9:21 PM

#555084 RE: Horseb4CarT #555072

Thanks to both you and Gary for the thoughtful replies. I understand both of you reasonably meant to suggest pressure on the FDA. That was not my intention as it would be counter-productive and possibly prejudicial. Rather. I suggest focusing, in part, on the policy structure in the Cancer Moonshot Initiative, particularly with regard to funding that could be used for other tumor-focused and/or combo trials. DCVax fits firmly within at least two of the Iniative's objectives.

"Establish a cancer immunotherapy research network to develop immune-based approaches for the treatment and prevention of cancer in adult patients.

Identify therapeutic targets to overcome drug resistance through studies that determine the mechanisms that lead cancer cells to become resistant to previously effective treatments."

Its a near certainty neither of the teams set up to implement these two objectives know of DCVax.

Washington often embodies a top-down way of doing business. Why not let the top know Northwest already has a proven means of extending the lives of glioblastoma patients without adverse side effects...a treatment that could be made vastly more effective over a wide range of solid tumors with adequate research funding and policy assistance?

Our competitors and detractors clearly know how this system works. Why don't we embrace the challenge and do what we can to make it work for us and those dying every day from this disease?

As you point out, timing is crucial, but so is preparation. Why not gather a group of shareholders with diverse skills to identify the best approaches and means to effect them? For example. I know a shareholder who ran a successful DC-based PR company for many years.

I realize many of us have a lot at risk with this investment and do not want to create impediments to its success. All the more reason to examine ways in which we can assist the company with policy and funding opportunities as they pursue the scientific, manufacturing and regulatory paths. Especially as the corporate leadership is already thinking about this themselves.

By the way, the Initiative is just one of several potentially effective targets to bring awareness and funding to Northwest's game-changing therapy.

Thanks again for your thoughts. Most of us want the best for Northwest, cancer patients and ourselves.