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KMDA

Kamada

$5.40

0.1 (1.89%)

07:03
07/10/18
07/10
07:03
07/10/18
07:03

Kamada receives positive scientific advice from EMA on study for Inhaled AAT

Kamada announced that it has received positive scientific advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the development plan for its proposed pivotal Phase 3 study for its proprietary Inhaled Alpha-1 Antitrypsin therapy for the treatment of alpha-1 antitrypsin deficiency. The Company requested scientific advice from the CHMP following the results of the previous Phase 2/3 and Phase 2 studies conducted by the Company with respect to a proposed subsequent Phase 3 study design. The CHMP notified the Company that it concurs with the overall design of the proposed study, including its objectives, patient population, proposed endpoints and their clinical importance, and the safety monitoring plan. The CHMP had some minor comments, which Kamada intends to address in the final study protocol. The EMA process is conducted in parallel with the Company's continued discussions with the U.S. Food and Drug Administration on the Phase 3 study of Inhaled AAT for AATD. As previously communicated, following feedback received from the FDA in April 2018, Kamada intends to provide the FDA additional requested information and data, as well as an amended study protocol, during the third quarter of 2018. The proposed modifications and additional information are intended to mitigate the continued safety-related concerns communicated by the FDA

KMDA Kamada
$5.40

0.1 (1.89%)

02/02/18
CHDN
02/02/18
INITIATION
Target $7
CHDN
Buy
Kamada initiated with a Buy at Chardan
Chardan analyst Keay Nakae initiated Kamada with a Buy and $7 price target.

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GOOG

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LGIH

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INVH

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FDX

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LYFT

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