Showing posts with label Notice. Show all posts
Showing posts with label Notice. Show all posts

Applications for r-DNA derived Drugs via #Sugam Portal Now



Through a recent notification, CDSCO has said that the filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal

The authority has decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be accepted through online mode only from 1st Feb 2018 and no offline applications will be accepted after that.

On November 14, 2015, the Central Drugs Standard Control Organisation has launched an online portal SUGAM (www.cdscoonline.gov.in) in pursuance of the implementation of E-Governance.

The notice states that a reference is also invited to the stakeholders meeting held on 10.01.2018 wherein it has been agreed upon that, filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal.

In view of above, it has been decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs shall be accepted only through online mode from 1st Feb 2018 and no offline applications will be accepted thereafter.



VIA Pharmaceuticals Receives Anticipated Deficiency Notice From NASDAQ

VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced that on September 15, 2009, it received a deficiency letter from the NASDAQ Stock Market stating that the Company is not in compliance with the minimum $1.00 per share bid price requirement for continued listing, as set forth in Listing Rule 5550(a)(2), and that the Company's securities are, therefore, subject to delisting from The NASDAQ Capital Market.

The Company has a period of 180 calendar days, or until March 15, 2010, to regain compliance with the minimum bid price listing requirement. If at any time during this grace period the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, the Company will receive written notification of its compliance with the minimum bid price listing requirement. In the event the Company does not regain compliance prior to the expiration of the grace period, the Company will receive written notification that its securities are subject to delisting. In such event, the Company may appeal NASDAQ's determination to a NASDAQ Listing Qualifications Panel (the "Panel"), which request will stay the delisting of the Company's securities pending the Panel's decision.

Additionally, the Company has had a hearing with the Panel regarding its failure to meet capitalization requirements for continued listing and is awaiting a decision from the Panel. There can be no assurance that the Company will regain compliance with the minimum bid price listing or capitalization requirements and maintain its NASDAQ listing.

NUCRYST Receives Deficiency Notice from NASDAQ

NUCRYST Pharmaceuticals, a developer and manufacturer of medical products that fight infection and inflammation, today announced that on September 15, 2009 it received notice from the Nasdaq Stock Market that it no longer complies with Nasdaq Marketplace Rule 5550(a)(2) because, for the previous 30 consecutive business days, the bid price of its common stock had closed below the minimum requirement of $1.00 per share. Receipt of this notification has no immediate effect on the NASDAQ listing of the Company's common shares. In accordance with Marketplace Rule 5810(c)(3)(A), the Company has until March 15, 2010 to regain compliance, which requires a closing bid price of the Company's common stock at or above $1.00 per share for a minimum of 10 consecutive business days. In the event the Company does not regain compliance within this period, Nasdaq will issue a written notification that the Company's shares are subject to delisting. If the Company is not deemed in compliance prior to March 15, 2010, but demonstrates that it meets all applicable standards for initial listing on the Nasdaq Capital Market (except the bid price requirement) on such date, it will be afforded an additional 180 day compliance period.

NUCRYST is currently evaluating its alternatives to resolve the listing deficiency.

La Jolla Pharmaceutical Company Receives Notice of Noncompliance with Nasdaq Stock Market Listing Requirement

La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced today that it has received a notice from the Nasdaq Stock Market indicating that the Company is not in compliance with Nasdaq Marketplace Rule 5550(a)(2) (the "Minimum Bid Price Rule") because, for the last 30 consecutive days, the bid price for the Company`s common stock has closed below the minimum level of $1.00 per share. In accordance with Nasdaq Marketplace Rules, the Company will be provided 180 calendar days, or until March 15, 2010, to regain compliance with the Minimum Bid Price Rule. This notification has no effect on the listing of the Company`s common stock at this time.

If the Company does not regain compliance with the Minimum Bid Price Rule by March 15, 2010, Nasdaq will notify the Company that its common stock will be delisted from the Nasdaq Stock Market.

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