Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 10

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 10
---
 application relates to a drug
that treats a serious condition and would provide a significant improvement in safety or effectiveness qualifying for Priority Review,
six months from the filing date. The review process is often significantly extended by FDA requests for additional information or
clarification.

The FDA offers certain programs, such as Breakthrough
Therapy Designation (“BTD”) and Fast Track designation, designed to expedite the development and review of applications for
products intended for the treatment of a serious or life-threatening disease or condition. For BTD, preliminary clinical evidence of the
product indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,
such as substantial treatment effects observed early in clinical development. If BTD or Fast Track designation is obtained, the FDA may
initiate review of sections of a BLA before the application is complete, and the product may be eligible for accelerated approval. However,
receipt of BTD or Fast Track designation for a product candidate does not ensure that a product will be developed or approved on an expedited
basis, and such designation may be rescinded if the product candidate is found to no longer meet the qualifying criteria.

The FDA reviews the BLA to determine, among other
things, whether the proposed product is safe, pure and potent, which includes determining whether it is effective for its intended use,
and whether the product is being manufactured in accordance with cGMP, to assure and preserve the product’s identity, strength,
quality, potency and purity. The FDA may refer an application to an advisory committee for review, evaluation and recommendation as to
whether the application should be approved, and applications for new molecular entities and original BLAs are generally discussed at advisory
committee meetings unless the FDA determines that this type of consultation is not needed under the circumstances. The FDA is not bound
by the recommendation of an advisory committee, but it typically follows such recommendations.

After the FDA evaluates the BLA and conducts inspections
of manufacturing facilities, it may issue an approval letter or a complete response letter (“CRL”). An approval letter authorizes
commercial marketing of the biologic product with specific prescribing information for specific indications. A CRL indicates that the
review cycle of the application is complete and the application is not ready for approval. A CRL may require additional inspections, and/or
other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. Even if
such additional information is submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria