Replies to post #3839 on Calypte Biomedical Corp (fka CBMC)

[vizsla4084]

Thanks, AxiomOne.

I have waited this long, I am pretty sure I can wait until the end of September.

[OttomanRosendahl]

R.Gale:

I would now like to give you a brief update on the Chinese SFDA approval process. We are meeting with SFDA personnel on at least a bi-weekly basis and have a much better understanding of the process of product approval in China.





Here is a brief recap of where we stand at the present.





·
The CDE Expert Technical review is DONE







·
The Leadership review is DONE








--------------------------------------------------------------------------------



·
Expert panel review is next. The CDE verbally told us last week that this panel will meet on December 4th and we are expecting written confirmation of this in the next few days. They have requested that our Chief Science Officer, Dr. Mink, be available for this meeting.







·
After the Expert review, the CDE will determine to accept or reject the application, to request additional info, or to reschedule us for later review because they feel it is not appropriate at this time. They have up to 30 working days (about 6 weeks) to review their findings and make a decision. Depending on that decision, they have up to an additional 30 working days to notify us of their decision.


is Done



·
If the decision is to request additional information, the CDE has 2 calendar weeks to provide us with a written request for the supplemental materials.







·
While technically we have up to 4 calendar months to submit supplemental materials, if necessary, we expect to be able to submit answers to any requests in a much shorter time.


is Done




·
Once we submit any requested materials to the CDE, they have 30 working days to process the supplemental materials and make a decision (accept, reject, request additional info, or schedule for later review)



is Done



·
If our application is approved, the CDE has 30 working days to prepare documents and submit the packet to the SFDA for final approval.







·
The SFDA can then take up to 40 working days (about 2 months) to issue its final approval to us.







This timetable reflects the regulatory limit and may not reflect the actual time it will take. While we do not control the approval process, we are optimistic that we can address any of the agencies’ concerns in a timely manner and, although we currently anticipate that we will receive approval, we cannot give you an exact date for that to happen. We have, however, had discussions with the SFDA and they do understand the unique attributes and benefits of this test. With a fourth quarter 2006 approval unlikely, and while the exact approval timing is unknown, we are optimistic and are planning on a marketing launch based around approval during the first quarter of 2007.