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GD

10/17/22 11:28 AM

#378341 RE: Steady_T #378338

Is it material it shows a clear success? We can reasonably to see
if AD failure, AVXL may go down to 5 and if AD success, AVXL
may go up to 50, which is more material in your opinion?
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peeved

10/17/22 11:30 AM

#378342 RE: Steady_T #378338

great point actually

certainly a failure is a material event...

but why wouldn't the opposite be true...a great success would be material as well wouldn't it?

I can certainly see further precision not being material as it is what the company has been doing for years...and unlikely to change share price.

I would imagine the following 2 may be at play but certainly negative is more material than positive.

Changes in earnings guidance; and
• Other materially different information regarding key financial or operations trends
from that set forth in periodic reports.

here is a list

https://www.sec.gov/about/offices/oia/oia_corpfin/princdisclos.pdf

Material events that are reported to the U.S. Securities and Exchange Commission on Form
8-K
The comprehensive list of prescribed corporate events that are presumptively material and that must
be disclosed, or will likely be required to be disclosed, with the U.S. SEC on Form 8-K is as
follows:
• Changes in control of a company;
• A company’s acquisition or disposition of a significant amount of assets;
• A company’s bankruptcy or receivership;
• Changes in a company’s certifying accountant;
• Resignations of a company’s directors, circumstances for the departure of a director,
the appointment or departure of a principal officer, and the election of new directors
other than pursuant to a vote of security holders at an annual meeting;
• Change in a company’s fiscal year and amendments to a company’s articles of
incorporation or bylaws that were not previously disclosed in a proxy statement or
other such disclosure document;
• Entry into a material agreement not made in the ordinary course of business;
• Termination of a material agreement not made in the ordinary course of business;
• Termination or reduction of a business relationship with a customer that constitutes a
specified amount of the company’s revenues;
• Creation of a direct or contingent financial obligation that is material to the
company;
• Events triggering a direct or contingent financial obligation that is material to the
company, including any default or acceleration of an obligation;
• Exit activities including material write-offs and restructuring charges;
• Any material impairment;
• A change in a rating agency decision, issuance of a credit watch or change in a
company outlook;
• Movement of the company’s securities from one exchange or quotation system to
another, delisting of the company’s securities from an exchange or quotation system,
or a notice that a company does not comply with a listing standard;
• Conclusion or notice that security holders no longer should rely on the company’s
previously issued financial statements or a related audit report;
• Any material limitation, restriction or prohibition, including the beginning and end
of lock-out periods, regarding the company’s employee benefits, retirement and
stock ownership plan;
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• Unregistered sales of equity securities by the company;
• Material modifications to rights of holders of the company’s securities;
• Earnings releases;
• Changes in earnings guidance; and
• Other materially different information regarding key financial or operations trends
from that set forth in periodic reports.
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WilliamMunny

10/17/22 12:21 PM

#378368 RE: Steady_T #378338

Steady (or anyone else), if "TLD data is not material UNLESS it shows a clear trial failure," how was Biogen able to release its Lecanemab data in contravention of the CTAD embargo? The trial was certainly not a clear failure, and they obviously got an exemption to the embargo. That exemption is for publicly traded companies whose counsel can successfully argue to CTAD that withholding the data from release would contravene SEC regulations.