austinmediainc,
The company will not get into open declarations of ramp up for commercial production. They already said they would do this once and do not want any heat from any source for over emphasizing this point. Low key is the MO during regulatory review and internal investigations.
A quick aside for those who have forgotten, Medical Center Cologne provided a great deal of supporting evidence for effectiveness of DC therapy and they adopted DCVax as their therapy of choice vs their own in house version.
The limiting factor for DCVax treatments if approved, more than anything else, is commercial production capacity sufficient to match projected demand. Full automation is anticipated in about 1 year for Direct so part of the foot dragging for Phase 2 must be related to this. The timing with automation and therapy approvals is critical for expeditious commercialization. All the regulatory approvals for production must receive top priority for this to happen. Hopefully, Mr. Woodford's investment has speeded up automation development and approvals can be announced sooner. Regulators do not want to look like the bad guys if results are exceptional and may be pushing a pathway that buys them and NWBO time to accomplish expedited commercialization at the current expense of stock price. There are greater concerns involved here than what investors present. Production capacity of a "breakthrough" technology MUST be able to realistically deal with expected demand. Regulators do not want to face the heat of desperate patients and their families if grest results ate announced publicly. HE reimbursement will help with ramp up costs but early release of excellent results could result in troubling demand issues so better to stay quiet as long as possible.
