Antwort auf meine Nachricht an Aeterna Zentaris
Hallo Leute. Ich hab hier noch was zum Lesen für Euch.
Würde mich außerdem auch über Informationen Eurerseits freuen.
Also hier wie versprochen:
.............
Mr. Nic,
Thank you for your interest in our Company. The facts in the Seeking Alpha article that you are referring to, are correct. However we cannot comment on the author’s speculation regarding the extent of dilution. We currently have over 136 million shares outstanding as of yesterday.
As for our drug development programs, below are the expected milestones for the remainder of the year:
Ø Phase 3 trial in endometrial cancer with zoptarelin doxorubicin
o Completion of patient recruitment in H1 2015 (imminent)
o Second interim analysis by year end 2015
Ø Confirmatory Phase 3 trial with Macrilen in AGHD
o Approval of the protocol design in Q3 of 2015
o Initiation of the trial in Q4 2015
It is very hard to comment on the outcome of clinical trials, as encouraging results from earlier trials are not necessarily guaranteed in much larger Phase 3 trials. However, we feel that we have two good products with good business potential.
As for the FDA’s refusal to approve our NDA for Macrilen, we stated in our November 214, 2014 PR: The Complete Response Letter further mentioned issues related to the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD. The FDA concluded that, “in light of the failed primary analysis and data deficiencies noted, the clinical trial does not by itself support the indication.”
Following meetings with the FDA and a panel of experts in the field of growth hormone deficiency, we decided to go ahead with a confirmatory trial in AGHD. Also, the European Medical Agency have stated the design of the trial submitted to the FDA, meets their protocol design expectations, which, if the trial is successful, could facilitate approval in Europe.
As for our commercial activities, below are some of the milestones to look for the remainder of the year:
Ø Start selling of EMD Serono’s Saizen (growth hormone therapy product) in Q3 2015
Ø Co-promotion, in-licensing and /or acquisition of additional already marketed products by the end of 2015
I hope this information will give you a clearer understanding of what we are trying to achieve for the benefit of both patients and shareholders.
Best regards,
Paul Burroughs
Director of Communications
Aeterna Zentaris
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