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It will be interesting to see in the next report how many additional C shares they have sold. That will give us some clue if a major institutional investor or pharma partner will come on board post MHRA approval or not. Or if their strategy is to continue to sell small quantity of C shares to their buddies every quarter.
I agree the worse it yet to come in the coming weeks.
Yeah, right. With your theory the MHRA ought to be have approved MIA within 30-60 days from application! ;) It doesn’t work that work in the biotech world.
First things first, they must apply and get their application accepted. The management will shout from the rooftop when that happens. The clock starts then. And then hope that the management didn’t fumble with their documentation and/or the regulatory agency does not ask for more data/clarification on existing data.
Missing CEO, haha!
Just don’t know how they would be able to list on a major exchange that quickly. That’s a major undertaking and I doubt they have the resources and time to do that.
My sense is we will continue to trade sideways or on downwards trajectory for another year or so…who knows may be they bring a credible institutional investor after MAA approval next year. But the question again will be why would this new institutional investor pay more than 2 or 2.5X of the trading price, particularly with the history of this management?
It’s dead money this year, unfortunately. It doesn’t look like we will get U.K. approvals this year either and the MMs + hedge funds will continue to manipulate even after MAA acceptance. As I predicted that MIA won’t move the needle, I am certain MAA acceptance won’t change anything. The usual culprits will come up with all kind of stories that it won’t be approved or it will only be approved for a small subgroup, etc. And the manipulation will continue. Only big, credible investor group(s) that come in at a much higher ceiling has the potential to change this. But that ain’t happening this year because they will be waiting until MAA approvals (in the best case scenario) or likely FDA approvals which may be 12-18 months and that too I am not confident this team can deliver in terms of timing given their history!
Interesting insight on one of the biggest pharma acquisition recently and the timing of Merck backing off.
https://www.fiercepharma.com/pharma/pfizers-43b-acquisition-seagen-biotechs-patience-paid
Gary,
If you go back to your end of 2022 Share Price projections from about 12-18 months ago, it was twice your current view for end of 2024. Could we again see the same pattern as we approach end of this year/beginning of next year? In that case, your end of 2025 or end of 2026 projection could be adjusted to half of end of 2024 forecast you currently hold.
The reality is this management has failed to deliver returns to the shareholders despite TLD, JAMA, MIA. Over 30 months from data lock and counting….
It wouldn’t be surprising if June comes and goes and there is no formal confirmation of MAA submission/acceptance.
Just curious - what are your Q1& Q2 revenue expectations? Or how many patients per month will they get to in Q2?
It wouldn’t be surprising if June comes and goes and we hear about one more hurdle again! ;)
It will be fairly insignificant without reimbursements in place. Once they start billing over a dozen or so patients per month, they will start shouting from the rooftop! Not happening this year, unfortunately.
None of the regulators need Flaskworks for approval. So they are definitely not waiting on that. Either it’s phase 2 combo results or just ineptitude of this management to put an application together in a timely fashion. If 30 months is not enough then I don’t know what is.
I agree with you. They have had 30 months to prepare for RAs. We are getting creamed because of the continuous delays and lack of trust in this management’s ability to deliver in a timely fashion. The problem has been that they are not able to execute aggressively and build excitement amongst credible investment community to force these MMs and hedge funds to stop playing their games.
Agreed. It’s not a switch they can flip and they can go from say $2M to $50M in annual revenue. There’s lot more to building biotech business than just partnering with an outside manufacturing contractor.
That’s also why all the revenue projections put out by loyal supporters here is crap. They can’t even get to $30-50M in annual revenue unless they drastically scale up their team. Things start breaking down! And when you hear such near term revenue projections from loyal supporters, it reflects badly on the company and creates an image of scam, particularly in the eyes of experienced folks.
Agreed. They are taking us for another ride, just like those PRs signaling TLD in months. And we all know how that turned out!
Will you stop posting if there is no official confirmation of RA submission or acceptance by end of June?
At what point do you lobby for a change in management or is this acceptable to you, say we move into July and yet no confirmation of RA submission/acceptance?
Still can’t believe how LG made that statement in summer 2020 that UK approval was imminent. Didn’t he understand some of the requirements and challenges at that stage? Unless imminent in his dictionary is between 3 and 4 years!
As predicted couple of days ago nothing will happen in April-May. There is always an excuse!
They are taking us for another ride. This will continue for months (just like their TLD guidance of months and we all know how that turned out). Incompetent & dishonest management team!
Agreed. It’s funny he was a lot more optimistic about the timing and overall value of NWBO in his previous reports! The fact that he is saying couple of months, it’s increasingly looking like this will get dragged for more than a couple of months. Wouldn’t be surprising if we go beyond end of summer!
I guess the next excuse is going to be - we want to be strategic about our regulatory filing and hence we have decided to apply to all 4 agencies simultaneously but we need some more time to accomplish this. Then as we approach the fall, the next excuse will be it would be strategic to wait for phase 2 combo results in early 2024, which will undoubtedly lead to expedited approval from all agencies in a few months….
Gary,
You know Kite was 700 employee company pre FDA approval before it was bought by Gilead for somewhere in between $10-15B. And this was all before they had any approvals and they were not generating any commercial revenue.
There are many business functions a company needs to thrive even for a single product biotech company where manufacturing may be outsourced. For example, simple things like: who gets dinged if FDA comes knocking after the quality control one day? How is CAPA handled on the NWBO side? Who manages the CRM and accounting for 100s of doses going out every month? How is training and awareness built outside the trial sites? Who works with hospital and reimbursement/private insurance administrators to handle contract and payment discussions? The list goes on!
His favorite excuse come early to mid May will be - “everything takes longer with NWBO!”
Agreed. They want to bill and milk as much as possible even though milestone based payments are part of some of the contracts. And it’s easy for these guys to take slight advantage of the situation when the other party have absolutely no idea what the hell is going on and what’s required.
I have worked with FDA, EU, and Asian regulatory consultants on the medical device side. While they are quite helpful in avoiding traps for unwary, keeping you abreast with the latest requirements and standards, verifying your documentation, and so on, it’s worth noting that they are also working with many biotech companies in parallel and the onus always falls on the company personnel to move the needle.
I reported a few times couple of years ago that they will struggle during the RA processes and will end up losing a lot of time without someone like Duffy given their inexperience.
Yup, they have trained the loyal followers to accept mediocrity in their performance. There will always be excuses!
Flip, I have never seen any successful biotech company complain about the number of pages and how extensive the applications are. There are simply no excuses for not being prepared to submit to all RAs (forget about just U.K.) 30 months post data lock.
By the way, if you go back and listen to Dr. Toms interview from January 2023 where they called the press and spoke highly about the landmark results, he said that he was told by LP at the SNO meeting in mid November that they were done with about 3/4th of the application at that time (not quite sure if he meant FDA or U.K. or both). But one can go back and check that Q&A discussion. Press had specifically asked about the FDA approval progress.
Thanks, I just read it. Not terribly surprising to me given the history of this management. Plus another red flag was when the usual culprits started to put April- early May timelines as if big news was around the corner.
Another strong forward indicator to me (as I have said on so many occasions in the past) is the commercial hiring activity. Since nothing has occurred in this regard on the NWBO side, that indicates regulatory and reimbursement approvals are still quite a bit away. We will see some of the job postings and that will be an indication that they are getting close (within 6-9 months). Unless of course they license commercial activity to a big pharma, which is looking increasingly unlikely given how their social media army is positioning them.
I haven’t been following the message board or news regarding NWBO lately, but what did he write about regulatory applications?
I have been busy with work and travels, but glad you are finally taking a different perspective. They have had 30 months to prepare and be ready to submit as soon as the MIA was approved. No excuses!
Got it. Then that’s positive, I guess.
LP would not take such risk if something big was brewing! They would stop all insider activity for months. No point risking it for a few hundred thousand shares when Marnix already has over 10s of millions of shares.
Speaking from personal experience when we were acquired a few years ago by a top 5 medical device company. I don’t think a partnership or big investment is coming as folks are expecting.
It appears he bought some last week. With the size of NWBO, it would be very hard to believe if Marnix as a CTO (and very likely in charge of their data and RA) does not know. It’s of course different at big outfits with hundreds and thousands of employees….
PM, if they had something in place wouldn’t Marnix’s recent purchase violate insider trading?
“First paragraph on Sawston was they had an investor wanting to spend money bringing this type of manufacturing to Silicon Fenn area. Tough to pass up.”
Again speculation and not confirmed news, but even if that was true that’s not the reason to put US plans on hold. They could have started contract negotiations with CRL in parallel while working on getting Sawston certified. This would have allowed them to apply to FDA long time ago because CRL is certified in the US and would be ready to go within a year or so.
My point was they should have directed the funding to CRL rather than wasting 30 months to get Sawston certified and not applying to any regulatory agency. Or they ought to have started CRL in parallel soon after data lock. Particularly when one market is 10X in revenue potential than the other you spent 30 months waiting for MIA. But you knew this already!
By the way, Vertex has been transparent in their communication with shareholders all along regarding their roadmap and review process including FDA. That’s simply not the case with this management. No official PR regarding the roadmap and FDA. Except to state in one of their quarterly report that we plan to submit to multiple regulatory agencies in 2023. Why can’t they be transparent if they everything was lined up and they were really close?
BS. We have been paying Advent for years! Not good utilization of funds as opposed to activating CRL. And that too for approximately 5% of the global oncology market vs 50%. And not to mention all the margin pressures that will typically come in the U.K. with the reimbursements unlike US.
DNDN had many other issues. The biggest being manual process for every dose unlike NWBO. Hence cost control was next to impossible and that’s what lead to their demise rather. NWBO production doesn’t have these issues. Plus DNDN went after prostate cancer which is not an unmet need. There are a bunch of approved treatments and the long term survival odds are very good. Over 90% 5-year survival rate, I think. So it was not going to fly anyway with the cost/benefit calculations. We don’t have any of these issues to deal with.
Gary,
They had 30 months to get CRL contract and manufacturing in place. As to some of the advance payment to CRL and/or the requirement of Flaskworks, that’s one of the worst excuses. First, Flaskworks is not required by FDA or any other regulatory approvals. Second, you don’t wait months and years for Flaskworks production to come online and delay the application. Instead you start generating revenue by getting approvals ASAP using manual production and gradually transition to semi or fully automated manufacturing by reinvesting some of that profit back in R&D. Third, if management was truly committed they wouldn’t have offered themselves true up and instead used those million of shares to invest in bringing CRL online when the share price was around $1.5 or so on so many occasions over the last 30 odd months. Or worst case, they could have requested additional authorized shares soon after data lock when share price was over $2 to fund some of the upfront CRL manufacturing costs.
I continue to believe they are waiting on ph 2 combo trial results to come out before applying to FDA. Perhaps MHRA is willing to approve based on ph 3 data alone, but FDA may have indicated they need to see more! Otherwise, I can’t think of any other reason to continue to delay FDA application for over 2 years when it gives you access to the most lucrative and biggest oncology market (around 50%) as opposed to waiting over 30 months to apply for U.K. (due to Sawston certification) which is only 5% of the global oncology revenue.
Again, there are a bunch of small and big pharmas that also go through the same requirements for their new product and ph 3 trials. However, they are typically able to cover those million pages in 6-12 months from data lock and BLA is accepted by then. We are over 30 months and all we still hear from the management is it’s tedious and time consuming, but we will be filing for approvals this year!
Agreed. I don’t think a partnership is coming anytime soon either. Marnix purchasing the shares last week indicate that that he had no material, public info at the time of purchase. If a partnership was being worked on, he would have known and been involved, I’d think.
Only LP and NWBO management would make such statements about applications being million pages and so on. It’s nothing new. Dozens of small and big pharmas apply for approvals of their products every year including cell therapies. No one complains and takes this long except NWBO!
I am not sure. Flip. What gives you the confidence that MHRA will approve in 80-90 days vs say 130-150 days? And importantly, what if additional info pertaining to the data is required during the review process?