NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Again One more time. Once they get ok with submittal in less than two weeks (so the approval clock will start) they can start applying for other RAs not simultaneously but some period between like a month or two. Look the other company flipper posted it did back in last June (UK) and then apply for FDA in July.

There are many factors involved in when companies submit to various RA.s

For starters, NWBO needs to have mfg capability. They have said they are talking with CRL, but not report of a contract. CRL is publicly stating (last earnings call) they are fairly busy and companies are reserving commercial capacity well in advance of possible approval to insure they have space. Also, the prep time for inspection is recommended at a year or so.

In the EU there has been sighting of a PIP being submitted or approved.

BTW, Flipper was wrong on his dates for the Vertex/CRISPER approvals.

Vertex PR

BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Apr. 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the rolling Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)

In Europe, the Marketing Authorization Applications (MAAs) for exa-cel were submitted in December 2022 and validated by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2023.

What is funny is that the same crowd of longs talking about how fast this MHRA approval was (10 months) are at the same time saying MHRA approves in only a few months. How can the fastest MHRA approval be 240 days or so when this one (supposedly fast) was over 300 days?