参考ADMA最近PAS的时间轴

--July 26, 2018 07:58 ET | Source: ADMA Biologics, Inc.

ADMA Biologics Receives PDUFA Date for BIVIGAM® Regulatory Submission

Prior Approval Supplement (“PAS”) to Amend the Biologics License Application (“BLA”) for BIVIGAM® is Supported by Data and Documentation Prepared Using ADMA’s Optimized IVIG Manufacturing Process Demonstrating Robust Reproducibility and Manufacturing Consistency PAS Submission Specifically Addresses BIVIGAM® Production Issues Identified in the 2014 Warning Letter and 2016 Compliance Inspection of Biotest Pharmaceuticals Corporation (“Biotest”)

The target action date for the PAS is October 25, 2018

--November 08, 2018 17:05 ET | Source: ADMA Biologics, Inc.

PDUFA target action date of December 18, 2018 for BIVIGAM®

--Dec. 19, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), announces that as of the time of this press release the Company has not received any formal written communication from the U.S. Food and Drug Administration regarding BIVIGAM’s Prior Approval Supplement under the Prescription Drug User Fee Act.

When the Company receives official written communication from FDA the Company will promptly provide appropriate disclosures.

--Dec. 19, 2018 (GLOBE NEWSWIRE) 

FDA Issues Complete Response Letter for PAS Drug Substance, Approves PAS for Drug Product

The FDA approved ADMA’s drug product PAS submission which was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did not request any information pertaining to compliance status, clinical study safety and efficacy nor any information requests regarding third party contract manufacturers and vendors. The CRL did not contain any requests for additional manufacturing runs. The Company believes the FDA comments to the drug substance PAS submission are addressable and resolvable. The Company will request a meeting with the FDA and plans to promptly provide the FDA with clarification and responses to the issues raised in the CRL. The Company looks forward to working with the FDA to resolve the outstanding issues identified in the CRL.

历史不知道会不会重演。ADMA收购的公司之前也吃过FDA的Warning letter.原先预计的时间是1025，后来被推后了两个月，原因未知，可能是发现package有问题。目前PTLA还没有接到推后通知。如果今天盘后都没消息，估计明天公司会发新闻稿吧。ADMA腰斩了。不看好PTLA可以考虑买点15put，很可能一把十倍

$Portola制药(PTLA)$ 

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