Cell Therapy News/Articles, page-17916

It's all very interesting. We should also think about why the FDA went with the 6 month review process rather than the 2 month process. In my view the FDA have already made a positive determination. They have gone with a 6 month review because our new BLA contains new data, the new data not only links old with new product and provides a extra level of potency assay that would limit the BLA to a two month review as per guidelines. It must contain what they consider substantial new data supporting efficacy and safety for the BLA to be given the 6 month review.
The data, Emergency usage in adults.
FDA have ruled that this protocol contains substantial new data supporting approval. We have the data for adults. Could a accelerated approval be also given for adults? This would be one way the FDA could be assured a confirmatory trial in adults. Head to head with Rux. in those that have high MAP scores letting those that have already failed 2nd line therapy access to our product.