Current Report Filing (8-k)
October 08 2015 - 4:45PM
Edgar (US Regulatory)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR
15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported) |
October 8, 2015 |
NORTHWEST BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware |
0-33393 |
94-3306718 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814
(Address Of Principal Executive Offices) (Zip Code)
(204) 497-9024
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
In response to an email
inquiry received from a shareholder, the Registrant responded as set forth in the response attached as Exhibit 99.1 hereto.
The information in
this Item 7.01, including the exhibit attached hereto, is furnished solely pursuant to Item 7.01 of Form 8-K. Consequently, such
information is not deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise
subject to the liabilities of that section. Further, the information in this Item 7.01, including the exhibit, shall not be deemed
to be incorporated by reference into the filings of the registrant under the Securities Act of 1933.
Item 9.01. Financial Statements and
Exhibits.
Exhibit No. |
Description |
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Exhibit 99.1 |
Response to shareholder |
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT
OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.
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NORTHWEST BIOTHERAPEUTICS, INC. |
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Date: October 8, 2015 |
By: |
/s/ Linda Powers |
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Linda Powers, Chief Executive Officer, Chairperson |
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EXHIBIT 99.1
Shareholder inquiry: What is
going on with the change in completion date of the Phase 3 trial on clinicaltrials.gov? Is there a new change or delay in
the trial?
Company answer: No, there
is no new change or delay in the Phase 3 trial. In all of our public presentations all year long, we have stated that we
anticipated finishing the recruitment this fall, and reaching the primary endpoint around approximately the end of summer or September
of next year. The clinicaltrials.gov profile was very out of date, and the change of date in that profile from September
of this year to October of next year simply conforms the clinicaltrials.gov profile to the information we have provided publicly
all year long, plus about a month of cushion to take account of the temporary hold on new screening for the trial as we announced in August.
We are also updating the profile to correct
the number of patients. As stated in all of our presentations for over a year, the total enrollment will be 348. The
clinicaltrials.gov profile was very out of date in listing 300. We will simply be conforming the number in the profile to
the number we have long presented publicly.
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