$1.00 Rules....Write the HELP Senate committee members, they are responsible for the drop and NOT requiring immediate SPA compliance. Special interests are literally killing Americans.
This 60 day BS was likely a political favor. It helped/helps AZN...who did AZN give money to? The ranking members of the Dem Senate HELP Committee, Senator Tom Harkin and Senator Barbara Mikulski...only committee members accepting donations from AZN.
Special Protocol Assessment Agreements.—The Committee is concerned about questions that have arisen in connection with the rescission of a Special Protocol Assessment Agreement (SPA), including fundamental questions concerning FDA’s adherence to the statutory and regulatory guidelines that apply to the SPA process as well as to questions concerning fairness to the sponsors. The Committee would like to reiterate that FDA is expected to adhere to the established standard as informed by the Congressional Record and the 1997 PDUFA Goals Letter.
The Committee is aware of FDA’s ability to rescind a SPA agreement reached under section 505(b)(5)(C)(ii) of the Food, Drug, and Cosmetic Act only if it demonstrates that ‘‘a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the testing has begun.’’
This standard is informed by the Congressional Record and the 1997 PDUFA Goals Letter. The Congressional report explains that Congress intended ‘‘that such agreements should be binding on both parties’’ except when ‘‘a substantial scientific issue has come to light after an agreement has been reached and testing has begun, which has a direct bearing on the safety or effectiveness of the product.’’
The Committee also expects that, as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.
To ensure agreement over the standard to rescind a SPA, the Committee directs FDA to report to the Committees on Appropriations of the House and Senate within 60 days of enactment of this Act regarding the standard by which FDA would rescind a SPA. Lastly, to ensure agreement over the standard to rescind a SPA, the Committee directs FDA to revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency’s interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements.
If a company trades for 30 consecutive business days below the $1.00 minimum closing bid price requirement, NASDAQ will send a deficiency notice to the company, advising that it has been afforded a "compliance period" of 180 calendar days to regain compliance with the applicable requirements.
Thereafter, if such a company does not regain compliance with the bid price requirement a second 180-day compliance period may be available. A company listed on The NASDAQ Capital Market may be eligible for an additional 180-day compliance period if it meets the market value of publicly held shares requirement for continued listing, all other initial inclusion requirements for the Capital Market, except for the bid price requirement, and provides written notice that it intends to regain compliance with the bid price requirement during the second 180-day compliance period, by effecting a reverse stock split if necessary.
Similarly, if a company listed on The NASDAQ Global Select Market or Global Market company is unable to comply with the bid price requirement prior to the expiration of its 180-day compliance period, it may transfer to The NASDAQ Capital Market, so as to take advantage of the additional compliance period offered on that market. Such a company must meet the $1 million market value of publicly held shares requirement for continued listing, and all other requirements for initial listing on The NASDAQ Capital Market (except for the bid price requirement), and provide written notice that it intends to regain compliance with the bid price requirement during the second 180-day compliance period, by effecting a reverse stock split if necessary. If a company does not indicate its intent to cure the deficiency, or if it does not appear to NASDAQ that it is possible for the company to cure the deficiency, the company will not be eligible for the second compliance period.
A NASDAQ Global or Global Select Market company that is in the Hearings Process for the minimum $1.00 bid price requirement can submit a transfer application ONLY if it meets the continued listing requirement for market value of publicly held shares and all other initial listing criteria (except initial bid price) for the Capital Market. If the application is approved, the company's securities will be transferred to the Capital Market. The company will be granted the balance of the second 180-day compliance period to resolve its $1.00 bid price deficiency.
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In order to regain compliance with the minimum bid price requirement, a security must have a closing bid price of $1.00 or more for 10 consecutive business days.
Although an automated computer system tracks each company's bid price on a daily basis, it is suggested that the company contact its Listing Qualifications Analyst via email continuedlisting@nasdaqomx.com or by phone at +1 301 978 8008 when it believes compliance has been achieved. NASDAQ will provide all compliance determinations, in writing, to the company.
Under certain circumstances, to ensure that the company can sustain long-term compliance, NASDAQ may require the closing bid price to equal or to exceed the $1.00 minimum bid price requirement for more than 10 consecutive business days before determining that a company complies. In determining whether to look beyond the 10 days, NASDAQ will consider, but is not limited to, the following factors:
Margin of compliance (the amount by which the price is above the $1.00 minimum standard);
Trading volume (a lack of trading volume may indicate a lack of bona fide market interest in the security at the posted bid price);
The market maker montage (e.g., if only one of eight market makers is quoting at or above the minimum bid price and the quote is only for 100 shares, then added scrutiny may be appropriate); and
The trend of the stock price (is it up or down?).
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Yes. NASDAQ views reverse stock splits as an acceptable method to regain compliance. If the company determines to implement a reverse stock split, it will need to log in to the Listing Center, complete a Company Event Notification, and remit the $15,000 fee at least 15 calendar days prior to the implementation of the reverse split.
Please note that this fee does not apply to companies that participate in the All-Inclusive Annual Listing Fee program.
