For all of YOU who think or believe that ZIOP already has the complete data analysis of Ph3 in its hands, but the company and execs choose to withhold it -- here is a little lesson for you:
Regulation Fair Disclosure ("Regulation FD" or "Reg FD" or "FD") adopted by the Securities and Exchange Commission ("SEC" or "Commission") on August 10, 2000 and aimed at curbing the selective disclosure (a.k.a. withholding from public) of material nonpublic information by issuers to analysts and institutional investors, Regulation FD requires that issuer discloses material information publicly and promptly.
Regulation FD defines the outer boundary for “prompt disclosure” to mean as soon as reasonably practical, but in no event after the later of (i) 24 hours or (ii) the start of the next day’s trading on the New York Stock
Exchange (regardless of where or whether the company’s stock is traded), in both cases after a senior company official learns of the disclosure.
So put your wild conspiracy scenarios to bed, and let's wait for the data...
Fortunately for all of us, this is a binary event that has only two possible results: Pali either WORKS or does NOT!
I'm betting on the former....So I'm long and of course anxious....
FDA approval of a trial is *in no way* an endorsement of the drug. Only if FDA believes the drug is harmful will it not approve a trial. FDA would approve a test of sterile water to cure cancer, if a sponsor wants to spend the money. Stopping a sponsor from wasting shareholder cash isn't the FDA's job.
1. A report on this form is required to be filed or furnished, as applicable, upon the occurrence of any one or more of the
events specified in the items in Sections 1 - 6 and 9 of this form. Unless otherwise specified, a report is to be filed or furnished within
four business days after occurrence of the event. If the event occurs on a Saturday, Sunday or holiday on which the Commission
is not open for business, then the four business day period shall begin to run on, and include, the first business day thereafter. A
registrant either furnishing a report on this form under Item 7.01 (Regulation FD Disclosure) or electing to file a report on this form
under Item 8.01 (Other Events) solely to satisfy its obligations under Regulation FD (17 CFR 243.100 and 243.101) must furnish such
report or make such filing, as applicable, in accordance with the requirements of Rule 100(a) of Regulation FD (17 CFR 243.100(a)),
including the deadline for furnishing or filing such report. A report pursuant to Item 5.08 is to be filed within four business days after
the registrant determines the anticipated meeting date
Fib, thanks for a response and you did bring up a good point.... To clarify, my post was directed towards some who have been insinuating that ZIOP knows the results and has shared them with a selected few while withholding the data from the public.
While you are correct that Reg FD does not directly or specifically address a time-frame requirement of a public company's duty to disclose non-public material info to outsiders and public; the Reg FD rules specifically mandate that all publicly traded companies must disclose material information to all investors at the "same" time.
However, when it comes to general legal guidelines on duty to disclose and the time-frames, one of the primary purposes of the Securities Act of 1933 is to require public companies to disclose information sufficient for investors to make rational investment decisions and, indeed, the federal securities laws, and exchange rules, explicitly require prompt disclosure of a broad range of information, both periodically and based upon the occurrence of certain events.
I'm sure no one here would argue with me if I say that for an R&D biotech company, Phase 3 data would directly fall under the umbrella of the "occurrence of certain events".