sind ja aus der Macrilengeschichte wieder mal fein raus.
Geht Macrilen den Bach runter, bekommen sie ihre eine Abfindung für ihren Verlust.
Sind die Studienerg. super verdienen sie richtig. Da könnte ich auch mal 20% halten.:-)
Glaube nicht das sich der Kurs bis zum 15.12 weit von den 3,6$ (Unitpreis) bewegt.
Wenigstens nicht nach oben! Nach unten ist durch eine schlechte News natürlich noch Luft.
Positive Ergebnisse vermute ich erst nach dem 15.12.
4.16 Make Whole . In the event the Company publicly announces or discloses by press release, on or before December 15, 2016, any developments relating to the confirmatory Phase 3 trial for Macrilen in the evaluation of adult growth hormone disorder (the “Macrilen Phase 3 Trial”) and the VWAP over the 5 days immediately following such public announcement or disclosure is less than the Per Unit Purchase Price, then the Company will make a cash payment to the Purchasers equal to the difference between the Per Unit Purchase Price and such VWAP multiplied by the number of all Shares then held by such Purchaser. If the Macrilen Phase 3 Trial results are publicly announced or disclosed by the Company at any time after December 15, 2016, the Company will be under no such obligation to make any cash payment whatsoever to the Purchasers.
http://secfilings.nasdaq.com/...20INC.&FormType=6-K&View=html
Könnte es nicht sein das ein Versagen Macs vor dem 15.12 berichtet wird?
E.5.1
| Primary end point(s)
| | Co-Primary efficacy variables will be 'Percent Negative Agreement' and 'Percent Positive Agreement' when using predefined cut-points of both GHSTs. |
| | E.5.1.1 | Timepoint(s) of evaluation of this end point | Evaluation of the Primary endpoints will be performed at two timepoints (i.e. during two separate visits per Growth Hormone Stimulation Test): For Test 1 on Day 1, for Test 2 on D8-28 (i.e. on one day within a time period from Day8 to Day28)
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| | E.5.2 | Secondary end point(s)
| Secondary efficacy criteria will be 'Percent Overall Agreement' and estimated sensitivity and specificity of both GHSTs when using predefined cut-points of both GHSTs.
Safety:
Adverse events, clinical laboratory and 12-lead ECG.
Other:
Test acceptance/Preference by Trial subjects and investigators.
Preliminary PK: Tmax and Cmax of macimorelin Plasma concentrations in the sampling period.
Preliminary PK/PD: Tmax for macimorelin vs Tmax for GH; Cmax for macimorelin vs Cmax for GH. |
| | E.5.2.1 | Timepoint(s) of evaluation of this end point | Evaluation of the secondary endpoints will be:
- efficacy related at two timepoints (i.e. during two separate visits per Growth Hormone Stimulation Test), as mentioned in Section E.5.1.1: For Test 1 on Day 1, for Test 2 on D8-28 (i.e. on one day within a time period from Day8 to Day28)
- safety related at four timepoints, i.e. at all four visits of this Trial (Screening visit, Test 1, Test 2, End-of-Trial visit)
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https://www.clinicaltrialsregister.eu/ctr-search/...2015-002337-22/DE
Der Secondary end point wird wohl nach dem Primary end point ausgewertet weden.
Was ist wenn der primäre scheitert, wird das nicht eventuell gleich berichtet?
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