Drug Fact Sheet Form
PHLburg Technologies Inc. reviews the completed Fact Sheet as its first step in deciding if a drug might solve its Customer’s Problem Statement. The more comprehensive the responses/descriptions, the more accurate and more timely will be PHLburg’s evaluation. If proprietary information must be disclosed to prepare a comprehensive response, PHLburg will sign a Memorandum of Confidentiality. If the answer to any question is “no”, please provide that answer. If you do not know the answer to any question, please indicate “I do not know.” “No” and “I do not know answers” are acceptable. In conclusion, from your answers to the Fact Sheet PHLburg and its Customer want to understand what is it that you have, what does it do, and what is your vision for what you have.
- NAME OF DRUG
- FORMULA, be as complete as possible without disclosing proprietary information.
- DESCRIPTION OF THE DRUG. BE AS COMPLETE AS POSSIBLE WITHOUT DISCLOSING PROPRIETARY INFORMATION. (The description should be several paragraphs encompassing a page or more in length. In describing your DRUG be certain the reader will clearly understand how your DRUG will solve the Problem Statement. At the conclusion of your answer complete this sentence, "The (insert the name of your DRUG) is unique because (state the unique properties of your DRUG)."
- COMPETITIVE PRODUCTS IN THE WESTERN MARKET. (Prepare two charts. In the first, list the Customer's performance
specifications. In the second, list at least 6 technical parameters to
evaluate the DRUG.
In the charts compare the DRUG and the competing current Western drugs, compare the DRUG’s perceived advantages over the Customer's specifications and the competition. Be certain to include the name or a sufficient description of the competing DRUG so reference checks can be made. Describe each advantage of the Drug in a paragraph of at least 5 sentences). At the conclusion of the answer complete this sentence, "For the first time (insert the name of your drug) solves (state the nature of what your drug accomplishes). Consult the Physicians Desk Reference when preparing this answer.
- APPLICATION OF THE DRUG, RECOMMENDED USE (Describe each intended use fully in a paragraph of at least 5 sentences). The response should follow the format found in the Physicians Desk Reference for a drug of the same category.
- ADVANTAGES OF YOUR DRUG TO THE DRUGS CURRENTLY AVAILABLE. (Describe each advantage in a paragraph of at least 5 sentences). Consult the Physicians Desk Reference when preparing this answer.
- DISADVANTAGES OF YOUR DRUG TO THE DRUGS CURRENTLY AVAILABLE. Consult the Physicians Desk Reference when preparing this answer.
- CLINICAL STUDIES – Attach a copy of all completed studies or describe in detail the trials that have been completed.
A. EFFICACY DATE
B. SAFETY DATE
9. INTELLECTUAL PROPERTY PROTECTION. (for each patent and trademark). (Be as complete as possible without disclosing any proprietary information.)
A. DATE PATENT APPLIED FOR
C. DATE PATENT ISSUED
D. WORLD WIDE STATUS (PTC)
E. ATTACH COPY OF PATENT APPLICATION, PATENT AND PTC
F. COMPLETE LIST OF AUTHORS
G. ARE ADDITIONAL PATENTS GOING TO BE APPLIED FOR RESULTS ACHIEVED AFTER THE CURRENT PATENT SUBMISSION
10. PRODUCT NAME OR DRUG’S FUNCTIONALITY
11. ALL INVENTORS' NAMES AND INSTITUTE-BUSINESS AFFILIATION
A. LOCATION (PHYSICAL ADDRESS AND ORGANIZATION) WHERE THE TECHNOLOGY WAS DEVELOPED
B. COMPLETE LIST OF OWNERS
C. COMPLETE LIST OF AUTHORS
D. LEAD SCIENTIST
12. CURRENT STATE OF MARKETING EFFORTS
A. DATE APPROVED FOR MARKETING IN RUSSIA
B. DATE SUBMITTED FOR U.S. FDA APPROVAL - Attach Certificate of Authority/ FDA Application
13. LICENSING EFFORTS TO DATE.
A. DATE BEGAN
B. DATE DISCONTINUED
C. COMPANIES CONTACTED, PERSON
D. CURRENT STATUS
E. IF DISCONTINUED, (State the reasons, using at least 5 sentences)
14. ADDITIONAL INFORMATION / COMMENTS. (Please include a list of relevant publications.)
Attach and sign a statement affirming that, to the best of your knowledge:
1. The information provided is true and complete
2. The information provided is not confidential
3. The information is not subject to any restrictions on its transfer