| | | The list I was given:
1. Organic chemist with large pharma company experience in many areas
manufacturing reg affairs, production etc.
2. Oncologist with large pharma experience including FDA interactions.
3. Regulatory Affairs Officer..Long experience including trials with
intratumoral delivery.
4. Clinical Trials Monitor. Long big pharma experience.
5. Statistician and statistical firms as needed.Again pharma experience.
6. CRO for foreign trials (multiple disciplines and specialties)
7. Ex head of derm from FDA for derm trial design and data
interpretation.
(so those criticizing derm trial designs are complete joke compared to
this guy).
8. Other reg affairs officers and FDA lawyer if/as needed.
9. Derm company officer (experienced big pharma marketing and deals
etc.)
10. Multiple chemical, production and analytical experts as needed.
1l. Several big pharma marketing/business experts. High level executive
types. Including international pharma marketing and deals.
12. Several investment banking relationships
13. Technicians, for example, a biochemist.. perform laboratory and
animal studies.
14. Not to mention, lawyers in many specialty areas (e.g. SEC, patents,
reg affairs etc.), accountants, financial experts.
And for clinical trials multiple experts are involved in setting up any
one site which include the doctors themselves and associates, multiple
committee members at the sites with wide variety of
disciplines..technical/medical experts, ethics, regulatory. All of which
have input into the trial designs and data interpretation after..
So just reading the "employee" list doesn't cut it and concluding just
four "employees" can't do it. Very uninformed opinion. One might ask,
attend meetings or read a little to have an informed opinion.. as
opposed to publishing the other kind of opinion in a chat.
Hiring more "employees" would just run up the expenses and wouldn't get
anything done faster..
Take a look at the time and expense other companies have taken. PVCT
well under in time and way under in expense. |
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