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I would like to ask some questions about 510(k) medical devices applications in the U.S.
1. 510(k) is divided into Traditional, Special, and Abbreviated. Does the company’s application belong to Traditional?
2. A comparison between subject medical devices and predicate medical devices (legally marketed medical devices) must be provided in the 510(k) application. What is the predicate medical devices for comparison of the company?
3. If the 510(k) application is approved, is additional certification or inspection of production site for the medical devices required?
1. Yes, the FDA has approved this case as an application under the Traditional 510(k).
2. This case follows the U.S. 510(k) requirements, and is a multi-faceted substantial equivalent comparison of indications, design, materials, safety, efficacy, labels, biocompatibility, standards, and other applicable characteristics, not just a comparison with a single product on the market.
3. 510(k) applications and quality system audit are carried out respectively by independent units at the U.S. FDA. Once the 510(k) notification letter is obtained and the product is registered on the FDA website, it can be officially sold. The quality system audit of the manufacturing plant is conducted by the FDA inspection unit according to the annual schedule after notification.
What is the progress of Fespixon to the market in Southeast Asian countries?
1. Has a written NDA been submitted in Singapore? Has the written review been started and priority review application been proposed?
2. Has an application for pre-review meeting been submitted or NDA data been directly submitted in Thailand?
3. What is the progress of the NDA in Malaysia?
4. Are still verification experiments the relevant NDA requires necessary to be performed in Southeast Asian countries?
1. The relevant data preparation and document translation have been carried out simultaneously with the CRO in accordance with the requirements of national laws and regulations for NDA in Singapore and Malaysia. NDA and priority review applications will be submitted at the same time in August.
2. The pre-review meeting had formally been applied for to the Thai FDA, and a written reply was received last week. Comments are scheduled to be received from the Thai FDA in early August.
3. Additional verification experiments have not been required by Singapore, Malaysia, and Thailand up to now. The requirement of the pre-review meeting will be applied for in the third quarter from the four other countries, Vietnam, the Philippines, Indonesia, and India.
1. Is the Chinese Approved Drug Names (CADN) of “Xiangleitangzugao” applied for by the company on its own initiative to the Chinese Pharmacopoeia Commission, or the Center for Drug Evaluation believes that a CADN is required and it is necessary to inform the Commission?
2. It is registered as the first innovative traditional Chinese medicine of category 1.1, and is coming into the market. In addition to the western medicine market, is there any plan to cooperate with the traditional Chinese medicine associations in Mainland China for promotion and enter the traditional Chinese medicine market there?
1. An NDA of ON101 is submitted to the National Medical Products Administration (NMPA) in Mainland China in accordance with regulations, which was reviewed by the Chinese Pharmacopoeia Commission and named “Xiangleitangzugao”.
2. ON101 is a new drug for natural medicines, and doctors of traditional Chinese medicine and Western medicine can prescribe it.
The company is currently applying for a drug permit license in Southeast Asia. Is everything going well with the competent authority?
Oneness has completed the consultation meeting with the Singapore competent authority, which confirmed that it would make a streamlined review without local clinical trials due to the Taiwan Certificate of Pharmaceutical Product (CPP). It also granted priority review of supporting documents to shorten the review time. Having communicated with the Malaysia competent authority in writing, the company will prepare the relevant documents and submit the New Drug Application (NDA). It will apply the experience in other ASEAN countries and India to accelerate market access. It will go smoothly for our antibody drugs to enter ASEAN countries according to the results of the current communication.
Has your company conducted a market survey on the approximate number of DFU patients in Japan?
According to the Japanese laws and regulations, should the clinical trial be carried out all over again (like it is in the United States) if you want to apply for a drug permit license (on Fespixon) and gain access to the Japanese market?
Does the company have any further strategies for viewing and planning the Japanese market?
1. According to IDF statistics, the number of diabetes patients in Japan is approximately 7.39 million. As to the Diabetes Research and Clinical Practice 2018, the prevalence of DFU is only 0.3% which makes about 22,000 patients with DFU in Japan.
2. Yes. Clinical trials must be conducted on the trial subjects of the Japanese race before gaining access to the Japanese market.
3. In conclusion, due to the low number of DFU patients in Japan and the high number of requirements for market access, it is currently not the main target market.
1. Are the patients qualified for the expanded access program (EAP)? Is it determined by the local medical practitioner in the United States?
2. Compared with the existing drugs sold on the US market, does ON101 meet other options such as “incomparable” or “meeting the needs of patients”? Theoretically, can the requests for expanded access program (EAP) proposed by all DFU patients in the United States be allowed?
1. The expanded access program (EAP) is established by the US FDA for serious or life-threatening diseases in the United States. If a US patient meets the EAP requirements, his/her local (US) practicing physician may apply to the FDA and Oneness Biotech. After reviewing and confirming that they are eligible, patients will be able to obtain drugs that have not yet been marketed through expanded access.
2. The application may be filed in case a patient cannot enter a clinical trial, and the medical practitioner believes that the patient cannot obtain other treatments that are equivalent or satisfactory.
Here are some of my questions:
1. According to the Fast Track Designation, the drugs are for the treatment of serious or life-threatening diseases. In this case, how does the DFU meets the aforementioned criteria? Is it classified by the size of the wound?
2. Is there a large number of patients in the United States that meet the description of question 1?
3. Assuming that there is a large number of people who meet the description of question 2, will there be additional profits other than the necessary costs?
1. Since DFU is considered by FDA as a serious or life-threatening disease with unmet medical needs, it is not classified by ulcer size.
2. Comparing to the 34 million diabetic patients in the United States, patients with pre-diabetes are approximately 86 million in number. According to 2014 Diabetes Care, a total of 132,835 American DFU patients were sampled from 2007 to 2010, and the average annual treatment cost per person was US$11,710. The 2017 global DFU epidemic systemic survey also reveals that there are approximately 4.4 million DFU patients in the United States.
3.Expanded access program (EAP) is the FDA’s policy to allow patients to obtain products that have passed “Fast Track Designation” through EAP for treatment before the drug is approved for marketing. Therefore, it is not a company’s profit-making policy.
Here are some of my questions about the US Expanded Access (Compassionate Use). What type of patients would be eligible for the Expanded Access (Compassionate Use), seriously ill or mildly ill? Or is this a choice to be made by the patients themselves regardless of being seriously ill or mildly ill? In addition, should patients who use this type of therapy be included in the results of the Phase III trial, or can they be partially selected and included by Oneness Biotech?
1. Since the FDA considers DFU a serious or life-threatening disease with unmet medical needs, DFU has not been classified as seriously ill or mildly ill.
2. For patients who meet the subject enrollment criteria for Phase III clinical trials in the United States, they can be enrolled in the clinical trial to receive medical treatment.
3.The FDA expressly stipulates that the results of drug treatment obtained through EAP have nothing to do with the clinical trial itself.
Does the acquisition of Fast Track Designation and Expanded Access Program for ON101 be helpful to the response to or the application of medical devices and marketing?
1. Since the Fast Track Designation (FTD) involves laws and regulations governing the drugs under research and development instead of medical devices, it has nothing to do with the application for medical devices.
2. The niche for passing FTD lies in that, at the same time Phase III clinical trial of ON101 is carried out, Oneness Biotech is able to simultaneously apply for a rolling review by providing FDA with a large amount of paperwork required for the review of drug permit license, including ON101-related pharmacology, toxicology, CMC, and pharmacokinetics paperwork. Since there are strict scientific and regulatory requirements for the application of drug permit licenses, Oneness Biotech is able to know in advance what is missing and what to make up. After the clinical trial is over, Oneness Biotech may also apply for priority review and accelerated approval, making the application for drug permit license both fast and precise.
Does the announcement that China CDE's acceptance of NDA applications a few days ago means that there is a consensus on the required documents, applicable provisions, and specifications for the application? According to your company's expertise, how long do you think this review process will take?
1.Oneness Biotech has first applied for a PNDA meeting and responded to the questions proposed by CDE. At the same time, Oneness Biotech also provides complete NDA data pre-review before obtaining consent and acceptance to enter the formal review process.
2.The review period depends on the review progress of the regulatory agency.
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