Brain-Tools

MSF Funding plan

Objectives:

Our overall objectives are to raise sufficient contributions (funds and services) and then use those contributions to:

  • complete pre-clinical and clinical testing of MSF;
  • obtain marketing approval for MSF; and then,
  • produce and distribute MSF at low cost to
    patients.

Estimated total funding for all 5 stages:  $ 31 million

Five Stages of our MSF development plan:

Estimated Budget

 

1.  First stage:
Develop components and capabilities for later stages

9 month duration
$ 1 million budget
Funded:  $ 1 million interest-free unsecured loan
in Oct. 2012 from James Summerton, Ph.D.

Startup expenses

$10,000

 

Facility, supplies, equipment, tech. services, personnel

Oct. – Dec. 2012

$60,000

Jan. – Dec. 2013 

$250,000

 

Purification, formulation, packaging, stability work

2 stability chambers

$17,000

FDA-approved prefab clean room

$30,000

other equipment 

$15,000

 

System for memory assessment

Sands Research

$100,000

U. of Oregon Psychology group

$50,000

 

Fundraising Program

Books

$24,000

Website

$20,000

Animation

$14,000

Consultants

$150,000

Operating Expenses

$40,000

Contributions (to U. Tex., PBS, etc.)

$20,000

Purchase of access to information relating to MSF
$ 200,000
_____________________________________
Total                            $1,000,000

2.  Second stage:
Pre-clinicals to support subsequent clinical studies and trials

1 year duration
$ 3 million budget
Funding: contributions in form of interest-free
un-secured loans from individuals via crowd-funding ?
(Our intention is to repay all such loans if and when
Brain-Tools becomes profitable, perhaps by 2016.)

3. Third stage:
24-Week exploratory clinical study to compare third-generation MSF to best second-generation drug for improving memory in Alzheimer’s patients (Aricept),
and to determine optimal dose of MSF for each patient.

1 year duration (includes 6 months for startup)
$ 16 million budget
Funding:  from organizations and government entities ?
(see below: Comments on funding stages 3 and 4)

4.  Fourth stage:
32-Week safety/efficacy clinical trial to more rigorously compare MSF to best second-generation drug (Aricept).

1 year duration (includes 5 months wind down)
$ 8 million budget
Funding:  from organizations and government entities ?
(see below: Comments on funding stages 3 and 4)

5.  Fifth stage:
Plan and begin construction of pilot plant for producing MSF therapeutics.

1 year duration
$ 3 million budget
Funding:  conventional bank loan ?
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Total for all 5 stages                     $ 31 million

Comments on funding stages 3 and 4

We envision that while some of the funding for the expensive third and fourth stages may come from continuing crowd-funding,  our hope is that much of the funding for stages 3 and 4 can be raised from organizations and government entities which have a strong interest in developing a better treatment for Alzheimer’s.  Specifically, we hope to persuade several of the following entities to make commitments for the needed funds:

a)  US National Institute of Aging (NIA)  (The top priority for NIA appears to be development of more effective treatments for Alzheimer’s);

b) US National Inst. of Neurological Disorders and Stroke (In animal studies MSF was effective in recovery of memory after induced stroke.);

c) The Veterans Administration (There is reason to believe that MSF will be effective in patients with Lewy body dementia, and the Vet. Adm. is seeing a large unexplained increase in veterans with this condition.);

d) The US Department of Defense (There is reason to expect that MSF will be effective in reviving memory in military personnel suffering from head injuries.);

e) The National Football League (There is reason to expect that MSF will be effective in reviving memory in persons suffering from brain trauma, as commonly occurs in many professional football players.);

f) Medicare/Medicaid (Medicare and Medicaid together spend more than $100 billion per year on care of Alzheimer’s patients.  We expect that MSF treatment for memory loss may save tens of billions of dollars every year in costs of such care.  This is based on a small pilot study wherein MSF-treated Alzheimer’s patients with improved memories recovered significant normal function and so required appreciably less care.).

If these larger and longer-term studies and trials confirm the outstanding results seen earlier in a pilot clinical trial with 15 Alzheimer’s patients (much greater memory improvement and substantially fewer adverse events relative to the second-generation drugs), then we expect that regulatory approval will come soon after completing these clinicals.