preparing a supportive campaign to assure NP 001 is made available to patients as soo

[edjohnson]

You are invited to join this new Google group.
Our group will serve as a vehicle for brainstorming, planning, and preparing a supportive campaign to assure NP 001 is made available to patients as soon as possible.
Key assumptions include:
- Neuraltus determines the treatment is safe and effective.
- Neuraltus decides by mid-November they will ask us to help them move forward.
- There is no intent for people who are in our group to put pressure on Neuraltus.

Supporters of ALSTUN who become members of this new Group are asked to not diminish in any way their current activity related to supporting ALSTUN. We ask all new members to consider becoming active in support of ALSTUN.

If it becomes obvious that this group is not needed, or is becoming ineffective it will wind down and gracefully terminate.

Initial ideas might include letters to congresspeople, letters and calls to the FDA, interaction with public media, fundraising, etc.
When you join the group please tell everyone who you are, what you would like to do to help, and give us your ideas.
We welcome active discussion that stays on target. We discourage flaming, we encourage civil discussion.

 

[edjohnson]

Assuming NP 001 proves to be safe and effective in the trial that just wrapped up we still have a very long and difficult journey ahead of us.

The FDA will require a phase 3 trial probably with several hundred patients and of long duration.

Our hope is that groups such as the newly formed group to support NP 001, and groups such as ALSTUN can become strong enough to have their voices heard by the FDA and by the pharmaceutical company to allow either accelerated access, meaning sometime this year, or expanded access.

If we are fortunate enough to convince the FDA to allow access prior to phase 3 there still are many hurdles. Hurdles such as completing an assessment of manufacturing capability, assuring that the production quantities meet strict guidelines, packaging, marketing, education, etc. if neuraltus is sold this could all take much longer....(see quote below from Richard posted yesterday on the new group)

With enough resources, talent, energy and funding we may be able to replicate what the HIV and cancer communities accomplished for their patients.

Ed

> I think its important to realize that Andrew has stepped down...the new CEO is a merger guy...that being said, every month at the Forbes Norris clinic there was a Genentech rep at the trial...I have heard rumors ...that are supported by the exit of Andrew ...that Genentech is going to buy them...we need to focus our efforts on Genentech.
>