These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application
(BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties.
If a new drug application (NDA) for LM-030 is approved, LifeMax may be eligible to receive a rare pediatric disease priority review voucher, which can be redeemed to obtain priority review for any subsequent NDA or biological license application
(BLA) and can be sold or transferred.
If a new drug application for the product is approved, the company is likely to be eligible to receive a rare paediatric disease priority review voucher that can be redeemed to receive priority review for any subsequent new drug application or biological license application
and can be sold or transferred.
phase 3 DETECT clinical study met its primary and all secondary endpoints, and the submission of the Biological License Application
FDA is planned for the Q4.
* -- Xiaobin (Victor) Lu, Ph.D., CMC reviewer, division of cellular & gene therapies at FDA, will outline a product life-cycle approach for developing potency assays for a CGT product from preclinical studies to the Biological License Application
Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application
for the 50- to 59-year age group is under review by the Food and Drug Administration.
If successful, the resulting data will provide the basis for a Biological License Application
(BLA) in the U.
The company also announced that is has confirmed with the US Food and Drug Administration (FDA), receipt of the first portions of its Biological License Application
(BLA) for Prochymal as part of a rolling submission.
We are pleased with the outcome of this analysis and will include these results in our proposed Biological License Application
If a new drug application for LM-030 is approved, LifeMax may be eligible to receive a rare pediatric disease priority review voucher, which can be redeemed to obtain priority review for any subsequent NDA or biological license application
and can be sold or transferred.
The firm will receive USD19.8m in initial funding to cover the vaccine development through phase I, with potential funding of up to USD312m if BARDA exercises all options to take the vaccine to phase three trials and a biological license application
filing in the United States.
Gobburu will present the results from his recent paper, “Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.” “Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application
(BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions.