Replies to post #704711 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

NWBO is closer to approval now than ever in the history of this company.

that is an 100% solid fact

[dennisdave]

Hello DansVans

I cant respond in a PM since I do not have a IHub subscription.
wonderful news and happy to hear that your family member is going in the right medical direction.

You asked me for my honest opinion.
I will give you my honest opinion.
I think NWBO will be sold for a price between $ 15 and $ 20 billion after UK or EMA approval. So with 1.5 O/S that's $10 to $14 per share
I do not see NWBO at present being able to initiate new medical trials.
I also do not see NWBO currently being able to sell support DCVAXL.
The only thing that would change my mind is when NWBO hires sales support, accounting, logistical etc staff.
When it announces the start of different new medical trials financed in cooperation with large pharma
And most importantly when Powers, Goldman and some others from the BOD stepped down from the board to be replaced by a younger BOD.

Since all these conditions will not happen, I think after UK approval or EMA approval, BIG Pharma will make an offer in the amount I mentioned.

[dennisdave]

No I dont think that the link you provided will speed up the approval process for DCVAXL in the US at all. The FDA page you referred to allows mutual inspection between the FDA and foreign regulatory authorities conducted within each other’s borders. The FDA will never give up control and will always be following its own approval process.

Flippers' claim that DCVAXL will be automatically approved by the FDA, after the UK has approved DCVAL, is false and misleading.

The problem that NWBO still has to overcome is that the FDA so far is still holding on its objection of NWBO not being able to provide individual patient-level data. For that reason, the American Brain Tumor Association expressed its concern with the FDA in May 2023 in raps.org
https://www.raps.org/News-and-Articles/News-Articles/2023/5/Stakeholders-want-more-clarity-from-FDA-on-using-d

An FDA proposal to require the inclusion of patient-level data in marketing applications may prevent the use of external controls for some rare diseases, the American Brain Tumor Association said in their comment. “[I]ndividual patient-level data (IPD) is not always available for many cancers and other rare diseases,” they wrote. “This is due to many barriers that interfere with data sharing in healthcare.

On the other hand, exwannabe's claim that the FDA will never approve DCVAXL for that same patient-level data reason is equally false. The final decision on the subject has not been made yet. Thankfully the MHRA is very reasonable and has no problem with this obstacle and will most likely approve.