Regulatory inspection of the underlining drugs or biological products for their commercial readiness is usually the LAST STEP in regulatory approving process for the underlining products.
It usually goes like this: a biotech company develops a drug or biological product; have a review meeting with RAs for submitting NDA or BLA; NDA/BLA submission for application; application reviewed; labeling; manufacturing facility inspection; drug/biological product approval or issuance of a response letter.
So why the company has decided to move this last step backward, or the company has actually delayed all other steps to close to or coincide with this last step?
Why it took MHRA a whole few months to finally set its feet on the facility for inspection. A merely caseload as excuse seems convenient not concrete.
Discount Linda's evil motives to fund Advent to a commercial scale at the cost of nwbio shareholders while maintaining this prolonged quiet period, because the odds of DCVax-L gets approved is very high and she can also build Advent after D is approved.
So is this recently happened MHRA inspection of Sawston facility is equivalent to the LAST STEP of the DCVax-L approval process, besides the obvious Advent license application?
So is it reasonable to think when MHRA issues a license to Advent, it in effect approves the commercial use of DCVax-L in UK at least?
Then within the next couple of months, we will see license issuance, shortly followed by approval of DCVax-L.
When approved, NWBio will easily be worthy of $10-20 billions in short to medium term which is equivalent to a share price in the range of about $10-20 per share.
Yes selling at merely $1 and $1.10 per share instead of buying or holding, the Linda friendlies Island boys and vulture funds have no brains.
