NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Dr Bala

The finalized and accepted SAP is what allows data to be unblinded without invalidating the methods used to measure it. Only blinded data can be looked at to determine choices for best methods to measure unblinded data. Bottom line is that it makes the most sense at this point for NWBO to do a hard data lock on or after the 4 year data set is complete in August. All other discussion about data up to that point is essentially related to developing the path to SAP finalization which should be close to if not already submitted for acceptance as flipper44 has suggested.
For those not familiar with expected timelines, regulators should accept or suggest ammendments in 30 or 60 days from SAP submission. Most would expect 30. After acceptance, data lock and top line can be done shortly thereafter in days to weeks. I assume that flipper44 and I agree that this will happen in August at the earliest and September at the latest. There is no more reasonable excuse to extend beyond this.
Solid share accumulation generally occurs starting 3 months out from expected positive news. The bears found opportunity to get some to sell shares before holiday vacations in July but now they must decide whether or not any good news has a chance to surface before August vacations in Europe. September is usually a big biotech news month and last August was when the Europeans were scheduled to have data from NWBO received and reviewed but that meeting was suspended for an indeterminate amount of time. One year from last August seems to be the unspecified mark to hit for some type of news with a slide to September possible. I expect Linda and Les are working on a BLA concurrently because of what they expect from data and this is where they earn every penny of what they have received to date. Peddle to the metal in my opinion means they are getting everything lined up to fill in the blanks for their BLA. Anything less than this type of effort would be hurting future patient opportunities for treatment and Linda wants this to get to patients ASAP. Share price appreciation would also be hindered by not having a good portion of the BLA ready to be finalized with data input and commercialization readiness. I guarantee you Linda is not sitting on her hands with this. Best wishes.