”Antisense Therapeutics Board Chair Dr. Charmaine Gittleson said: “Tremendous effort has gone into the implementation of the substantially revised clinical development strategy as advised by the Company just over six months ago.
The revised approach necessitated modifications to the trial protocol and regulatory submission documents, which in turn impacted the many supporting elements of the clinical trial. In addition, identification of new countries, study investigators, and trial sites was necessary and bespoke trial applications had to be submitted into each of the selected countries.
We have only been able to achieve all these aspects, within this timeframe, through the dedication and hard work of our internal team and good collaboration with the trial sites, Parexel and other vendors.
We are pleased then to see the validation of our Clinical and Regulatory team’s perseverance via the CTA acceptance and approvals now coming though from the regulatory authorities and gratified to be on the doorstep of launching this clinical trial and bringing this much needed therapy to the DMD community.”
People who don’t understand the complexities of a Biotech trial.Will bitch about the time it takes to sign off on a trial being accepted.
As CG says in the announcement this am.
I really do hope that people on this thread know it’s all systems GO ! and the extra monies will come when the Board decides.$$
Yes ! Bulgaria was my biggest worry but that’s been put to bed…
We wait !
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Ann: PIIb DMD trial approved in Bulgaria- UK, Australia advancing, page-22
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