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| related topics |
| {product, candidate, development} |
| {product, liability, claim} |
| {property, intellectual, protect} |
| {personnel, key, retain} |
| {product, market, service} |
| {acquisition, growth, future} |
|
|
We have no manufacturing capacity, and we have relied and expect to continue to rely on third-party manufacturers to produce our product candidates.
We may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates or those that we in-license.
If third parties on which we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We have licensed in rights to CA4P, OXi4503 and other programs from third parties. If our license agreements terminate, we may lose the licensed rights to our product candidates, including CA4P and OXi4503, and we may not be able to continue to develop them or, if they are approved, market or commercialize them.
We will be required to raise additional funds to finance our operations; we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us.
Our products are subject to extensive government regulation, which results in uncertainties and delays in the progress of our products through the clinical trial process.
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business.
Our industry is highly competitive, and our products may become technologically obsolete.
We depend extensively on our patents and proprietary technology, and we must protect those assets in order to preserve our business.
We depend heavily on our executive officers, directors, and principal consultants and the loss of their services would materially harm our business.
Our products may result in product liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover any claims.
Full 10-K form ▸
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