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The conclusion is. A new CDMO CAN get a manufacturing license without having a client with a product in approval process. If NWBO would not exists Advent could still get a manufacturing license for cellular therapies without any client.
A CDMO can not get a client to produce cellular therapies for the client will say come back when you have a license. The MHRA will then not say you must have that client first to get our Manufacturing license for the CDMO would get stuck in a infinite black box.
yes so a company can get a manufacturing license FIRST (as in before the MA of the product) provided and on the condition the product is in the process of being approved. The MHRA does NOT say if the product is NOT in the process of being approved then you can NOT get a manufacturer license. You will NOT get a MA license but it doesnt say you wont get a manufacturing license.
Let me ask you this.
Can cognate bioservices charles river get a manufacturing license for producing DCVAX L without DCVAX L being in the approval stage? I bet they can.
Seagen is Keytrudas substitute thats clear
We are many years away from Merck buying DCVAX L years.
First DCVAXL needs to be approved by all RA's then we need 2 solid years of revenue.
Even after MHRA approval, Merck is not going to pay more than 15 billion for NWBO and LP is not going to accept anything less than 25 billion.
thanks senti I appreciate it
its good to see you take stands for Northwest I knew you would come around. Tomorrow buy 200k shares at opening :)
ok thanks I Googled for it, could not find it, you just saved me a lot of time I appreciate it
I still have trouble finding MHRA rule, guidance and or reg that stipulates for a CDMO to be eligible for a commercial certification a product/med/drug needs to be in the approval process.
It would be incredibly helpful if someone would quote the MHRA on that.
this I agree with you on Yes. Good explanation thanks
If thats the case then I would love to have seen NWBO PRing this
Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of DCVAX-L has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)
But it says this:
Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)
I cant believe we are discussing here if something that has been written in black and white by NWBO actually means what it says it does.
cellular therapies include DCVAX-L but not exclusively
animals include horses but not exclusively
Brickel announced its positive stat significant TLD on Oct 7 2021
https://ir.brickellbio.com/news/detail/70/brickell-biotech-announces-positive-topline-results
and got battered with a 50% SP haircut in the weeks after that
https://www.google.com/search?q=brickell+biotech+stock&rlz=1C1CHZN_nlNL1004NL1004&oq=brickell+biotech+stock+&aqs=chrome..69i57j35i39j0i512l3j0i22i30l2j69i60.3343j1j7&sourceid=chrome&ie=UTF-8
Interesting also is they got a 1 for 45 reverse split and its SP went all the way down the toilet still. (For those who think a reverse split is a guaranteed remedy for NWBO SP)
https://ir.brickellbio.com/news/detail/84/brickell-biotech-announces-1-for-45-reverse-stock-split
Im convinced the JA is being held up in anticipation of the FDA release (on Northwest's request?) of official regulation on the ECA comparison to satisfy one or more stubborn reviewer(s) concern. Alas, hope Im wrong.
Yes I understand but since its still a combo patent, even though DCVAXL plays the most important role in that patent, I cant imagine that combo patent to exist without Merck approval. NWBO would never want to risk a lawsuit with Merck over this. IMO
The only way your investment strategy holds merit is if your last NWBO transaction did not bring you a net loss. If it did then you are only fooling yourself by starting all over. In other words the real derisking in investing in biotech especially NWBO is following the stock and getting in as late as possible for as low SP as possible. So in that sense, I understand what you mean.
Many here have been holding NWBO stocks for many years only to see their opportunity cost increase (missing out in the overall stock market) and their investment dwindle. All those who came late to the party heck even last week are way better off than those holding for years even if they bought at 30 and averaged their NWBO SP cost down (provided they made money in the general market).
I thankfully bought a huge number of shares at 40 cents sold a large portion at 1.9 and bought back at an average of 90 cents.
I agree with your post it would be absurd if indeed there are journal reviewers still demanding ECAs to be set in stone by the FDA. Infuriating. Still, I think that's whats the reason for the JA delay, NWBO seeking further FDA guidance set in stone to satisfy these %^$#^ grrr JA reviewers.
Hey btw I HOPE IM WRONG on this one !
Great thinking PM thanks
I have heard someone saying once that LG said something to the effect of what you are speculating about. I dont know if its true and it is the big BSer LG. But still.
Ok you said SPA not SAP I went over your post fast and misread, the two can easily be misread.
Doesn't matter. You went off rails with a completely different subject than what I was posting about.
reread what I posted, you are on a completely different subject and reframing what I said.
you don’t have anything here to contribute then the sentence very long NWBO
Laughable
yes this is quite significant for Northwest's relationship with Merck.
This patent would never have occurred without Mercks' consent. That is something to pounder.
nope incorrect
have a good one
shorts/bears do not attack strong solid biotech who has everything in order unless they want to commit financial suicide and lose incredible amounts of money. That is just the law of the stock market jungle. Every flaw of every biotech is being punished immediately on the stock market and NWBO has plenty and on May 10th had plenty.
Wasnt that btw the whole premises of Northwest to have ALL duck in a row to postpone TLD and have EVERYTHING in order so that shorts cant attack. Thats what you have been saying as well all that time, go back and read your own posts. So they didnt and what they want to avoid from happening happened.
yes agreed so NWBO was a wounded easy pray Dolphin. Had they done what the market nowadays expects of biotechs then it would most probably not have happened. Back in the day of Dendreon when they released TLD, TLD was enough now biotechs have to do much more to beat off short sharks. NWBO didnt
I really believe LP thought "the data will speak for itself and the SP will then take care of itself" as in the time of TLD Dendreon. They could have known these days are over.
Ike
compare it with this,
If sharks would go after a healthy dolphin they will have zero chance. But a wounded small swimming dolphin would be devoured by sharks.
And that is exactly what happened on May 10th. NWBO was easy pray THUS shorts tore it apart longs followed in panic. Thats not blaming shorts that's NWBO not being a strong enough dolphin.
brickell biotech
is the first on top of my head for others I will back come later
switch the n with h and thats what NWBO shareholders are left with ;)