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related topics |
{product, candidate, development} |
{stock, price, share} |
{personnel, key, retain} |
{operation, international, foreign} |
{product, liability, claim} |
{property, intellectual, protect} |
{interest, director, officer} |
{cost, contract, operation} |
{product, market, service} |
{control, financial, internal} |
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Because of our immediate need for capital, our ability to continue as a going concern is in question.
We now conduct all AC Vaccine manufacturing out of our Lyon, France facility, which creates business uncertainties and logistical risks for the treatment of patients in our clinical trials.
We may not be successful in revalidating our Philadelphia facility, and may be unable to produce vaccines at that facility in the future.
We will be required to produce the vaccine for commercial purposes from the same facility at which vaccines were produced for clinical trial purposes, which may limit our manufacturing options after regulatory approval is received.
The U.S. clinical trial and regulatory approval process for our products has been and will continue to be expensive and time consuming and the outcome uncertain.
The European regulatory approval process for our products has been and will continue to be expensive and time consuming and the outcome uncertain.
We utilize two products in our AC Vaccines or clinical trials that are produced by third parties, and the unavailability of those products could adversely affect our regulatory approval process in the U.S. or Europe.
We compete with other clinical programs and other treatments for patients for our clinical trials, which will affect our ability to enroll quickly our clinical trials.
We raise capital in U.S. dollars, but have significant expenses in France, which exposes us to currency exchange rate fluctuation risk.
We are operating in a regulated industry where the guidance for acceptable manufacturing and testing of our products and processes is evolving, which creates uncertainties, delays and expense for us.
We are a development stage biopharmaceutical company, and we may never develop or successfully market any products.
Even if our AC Vaccine technology receives regulatory approval and is determined to be safe and effective, our products may not gain commercial acceptance.
If governmental and insurance reimbursement is not available or is insufficient, a market for our products may never develop or be economically feasible.
We may lose control over the development, marketing and distribution of our vaccines if we enter into third party arrangements to perform or assist us in performing any of those functions.
Current and future legislation may make our products unprofitable.
We may not be able to control the pricing of our products overseas.
We may not be able to obtain or defend our patents or operate without infringing upon the rights of others.
We are heavily dependent upon the personal reputation and personal contacts of our Chief Medical Officer, and the loss of his services could materially adversely affect our plan of operation.
We have recently appointed a new Chief Executive Officer, and the transition to a new Chief Executive Officer could disrupt our plan of operation.
We may not be able to compete with other companies, research institutes, hospitals or universities that are developing and producing cancer treatment products and technologies.
The trading volume of our common stock is relatively low and a more active market may never develop.
Our common stock was delisted from NASDAQ in 2003, which will continue to have an adverse impact on the liquidity and pricing of our common stock.
Because our common stock is a penny stock, you may have difficulty selling our common stock in the secondary trading market.
The rights of our preferred stockholders are superior to the rights of our common stockholders.
Full 10-K form ▸
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