I've not found a link to Les G's appearances on the investment show, but I believe it was there that he indicated that he expected a BLA would be filed by the end of this year. Those webcasts were last year, they were prior to the quiet period being declared, and I could be wrong, but that's what I believe he said.
As for developing the BLA, many months ago it was a hot topic here. Several much more knowledgeable posters than me brought up the various ways that development and approval could be expedited, many included the rolling BLA in which completed parts of the BLA are submitted separately. I gather that those that are submitted undergo immediate review, and if revisions are deemed necessary the company is notified of the changes deemed necessary. I may be wrong about this, but I don't know of another advantage to submitting the BLA in sections if those sections aren't being reviewed and the company advised of questions or omissions noted in the review.
It's my belief that the company has worked closely with the four regulators in establishing the SAP which changed the trial goals as documented in the European versions of Clinical Trials. I believe they continue working closely in developing the BLA that each of the regulators ultimately will act on. Clearly changes in the way the regulators operate are keys to the acceptance of the data using historical data rather than a control group in trials. These changes aren't specifically for the DCVax-L Trial, I believe the regulators are recognizing that for deadly diseases a trial can be designed where all who volunteer for the trial receive the experimental treatment. In the future I believe we'll see many trials that are run in this way.
Gary
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