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That’s for trials.
…. We will need to wait for further detail before we know whether the MHRA will be able to accelerate these timelines even further.
I think he fell asleep near a pod.
Announcing when validation occurs places many things in motion including commercialization launch prep, combo deal finalizations, government prep, institutional prep, hospital prep, etc. Shorts and fake longs and swoop traders don’t want validation announced because it means their games are coming to an end. IMO.
Both NWBO and Canada NWBO are hoping for 150 day review*, (once validated) but both recognize the possibility of regulator questions at 80 days and the possibility of brief clock/calendar stop, before resuming 70 final days (if questions at 80 days).
* This shortened review can be achieved in a couple different ways.
Here are 18 (see below) Hoffman, not one, and it just scratches the surface.
(Also Bard came to the opposite conclusion when I asked it, you are confusing premature announcements with concurrent validation announcements.)
(Also, you recently stated you’d be “pleasantly surprised” if they announced validation.🤔)
If we followed your advice to not announce validation (which is against NWBO’s position), the first thing KG would say is, look, those guys wouldn’t even save their own skins by announcing acceptance/validation by a regulator.
Second, here is a sampling I created, with AI help, of drug and biologic companies announcing MHRA validation. It barely scratches the surface.
1.
Immunic, Inc. Announces MHRA Validation of Marketing Authorization Application for Onvapt® (nafamostat mesilate) for the Treatment of Pancreatic Cancer (November 9, 2023)
2.
Pharming Group N.V. Announces MHRA Validation of Marketing Authorization Application for Vimizim® (elosulfase alfa) for the Treatment of MPS VI (October 26, 2023)
3.
Horizon Therapeutics plc Announces MHRA Validation of Marketing Authorization Application for Krystexxa® (pegfilgrastim) for the Prevention of Febrile Neutropenia in Patients with Non-Small Cell Lung Cancer Receiving Chemotherapy (September 22, 2023)
4.
Aeglea Biotherapeutics Announces MHRA Validation of Marketing Authorization Application for Pegzilarginase for Arginase 1 Deficiency (August 15, 2023)
5.
Albireo Pharma Announces MHRA Validation of Marketing Authorization Application for Bylvay® for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (July 7, 2023)
6.
BioMarin Pharmaceutical Announces MHRA Validation of Marketing Authorization Application for Palynziq® for the Treatment of Phenylketonuria (PKU) (June 15, 2023)
7.
Ipsen Announces MHRA Validation of Marketing Authorization Application for Cabometyx® (cabozantinib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) (May 24, 2023)
8.
Jazz Pharmaceuticals Announces MHRA Validation of Marketing Authorization Application for Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for the Treatment of Idiopathic Hypersomnia (IH) (April 12, 2023)
9.
UCB Announces MHRA Validation of Marketing Authorization Application for Bimzelx® (bimekizumab) for the Treatment of Moderate to Severe Plaque Psoriasis (March 8, 2023)
10.
Vifor Pharma Announces MHRA Validation of Marketing Authorization Application for Veltassa® (patiromer) for the Treatment of Hyperkalemia (February 1, 2023)
11.
PTC Therapeutics Announces MHRA Validation of Marketing Authorization Application for Upstaza® (eladocagene exuparvovec) for the Treatment of AADC Deficiency (January 4, 2023)
12.
Neurocrine Biosciences Announces MHRA Validation of Marketing Authorization Application for INGREZZA® (valbenazine) Capsules for the Treatment of Tardive Dyskinesia in Adult Patients (December 7, 2022)
13.
Astellas Pharma Inc. Announces MHRA Validation of Marketing Authorization Application for Xospata® (gilteritinib) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation (November 10, 2022)
14.
AstraZeneca PLC Announces MHRA Validation of Marketing Authorization Application for Imfinzi® (durvalumab) for the Treatment of Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) after Concurrent Chemoradiation Therapy (October 17, 2022)
15.
Bristol Myers Squibb Announces MHRA Validation of Marketing Authorization Application for Breyanzi® (lisocabtagene maraleucel) for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (September 20, 2022)
16.
Gilead Sciences Announces MHRA Validation of Marketing Authorization Application for Trodelvy® (sacituzumab govitecan-hziy) for the Treatment of Metastatic Triple-Negative Breast Cancer (TNBC) (August 16, 2022)
17.
Pfizer Inc. Announces MHRA Validation of Marketing Authorization Application for Lorbrena® (lorlatinib) f2022or the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (July 5, 2022)
18.
Merck & Co., Inc. Announces MHRA Validation of Marketing Authorization Application for Keytruda® (pembrolizumab) for the Treatment of Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors (June 13, )
AEKusterer, I disagree on both counts
If we followed your advice (which is against NWBO’s position), the first thing KG would say is, look, those guys wouldn’t even save their own skins by announcing acceptance/validation by a regulator.
Second, here is a sampling I created, with AI help, of drug and biologic companies announcing MHRA validation. It barely scratches the surface.
1.
Immunic, Inc. Announces MHRA Validation of Marketing Authorization Application for Onvapt® (nafamostat mesilate) for the Treatment of Pancreatic Cancer (November 9, 2023)
2.
Pharming Group N.V. Announces MHRA Validation of Marketing Authorization Application for Vimizim® (elosulfase alfa) for the Treatment of MPS VI (October 26, 2023)
3.
Horizon Therapeutics plc Announces MHRA Validation of Marketing Authorization Application for Krystexxa® (pegfilgrastim) for the Prevention of Febrile Neutropenia in Patients with Non-Small Cell Lung Cancer Receiving Chemotherapy (September 22, 2023)
4.
Aeglea Biotherapeutics Announces MHRA Validation of Marketing Authorization Application for Pegzilarginase for Arginase 1 Deficiency (August 15, 2023)
5.
Albireo Pharma Announces MHRA Validation of Marketing Authorization Application for Bylvay® for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (July 7, 2023)
6.
BioMarin Pharmaceutical Announces MHRA Validation of Marketing Authorization Application for Palynziq® for the Treatment of Phenylketonuria (PKU) (June 15, 2023)
7.
Ipsen Announces MHRA Validation of Marketing Authorization Application for Cabometyx® (cabozantinib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) (May 24, 2023)
8.
Jazz Pharmaceuticals Announces MHRA Validation of Marketing Authorization Application for Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for the Treatment of Idiopathic Hypersomnia (IH) (April 12, 2023)
9.
UCB Announces MHRA Validation of Marketing Authorization Application for Bimzelx® (bimekizumab) for the Treatment of Moderate to Severe Plaque Psoriasis (March 8, 2023)
10.
Vifor Pharma Announces MHRA Validation of Marketing Authorization Application for Veltassa® (patiromer) for the Treatment of Hyperkalemia (February 1, 2023)
11.
PTC Therapeutics Announces MHRA Validation of Marketing Authorization Application for Upstaza® (eladocagene exuparvovec) for the Treatment of AADC Deficiency (January 4, 2023)
12.
Neurocrine Biosciences Announces MHRA Validation of Marketing Authorization Application for INGREZZA® (valbenazine) Capsules for the Treatment of Tardive Dyskinesia in Adult Patients (December 7, 2022)
13.
Astellas Pharma Inc. Announces MHRA Validation of Marketing Authorization Application for Xospata® (gilteritinib) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation (November 10, 2022)
14.
AstraZeneca PLC Announces MHRA Validation of Marketing Authorization Application for Imfinzi® (durvalumab) for the Treatment of Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) after Concurrent Chemoradiation Therapy (October 17, 2022)
15.
Bristol Myers Squibb Announces MHRA Validation of Marketing Authorization Application for Breyanzi® (lisocabtagene maraleucel) for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (September 20, 2022)
16.
Gilead Sciences Announces MHRA Validation of Marketing Authorization Application for Trodelvy® (sacituzumab govitecan-hziy) for the Treatment of Metastatic Triple-Negative Breast Cancer (TNBC) (August 16, 2022)
17.
Pfizer Inc. Announces MHRA Validation of Marketing Authorization Application for Lorbrena® (lorlatinib) f2022or the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (July 5, 2022)
18.
Merck & Co., Inc. Announces MHRA Validation of Marketing Authorization Application for Keytruda® (pembrolizumab) for the Treatment of Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors (June 13, )
AEKusterer, I disagree on both counts
If we followed your advice (which is against NWBO’s position), the first thing KG would say is, look, those guys wouldn’t even save their own skins by announcing acceptance/validation by a regulator.
Second, here is sampling I created with AI help of drug and biologic companies announcing MHRA validation. It barely scratches the surface.
1.
Immunic, Inc. Announces MHRA Validation of Marketing Authorization Application for Onvapt® (nafamostat mesilate) for the Treatment of Pancreatic Cancer (November 9, 2023)
2.
Pharming Group N.V. Announces MHRA Validation of Marketing Authorization Application for Vimizim® (elosulfase alfa) for the Treatment of MPS VI (October 26, 2023)
3.
Horizon Therapeutics plc Announces MHRA Validation of Marketing Authorization Application for Krystexxa® (pegfilgrastim) for the Prevention of Febrile Neutropenia in Patients with Non-Small Cell Lung Cancer Receiving Chemotherapy (September 22, 2023)
4.
Aeglea Biotherapeutics Announces MHRA Validation of Marketing Authorization Application for Pegzilarginase for Arginase 1 Deficiency (August 15, 2023)
5.
Albireo Pharma Announces MHRA Validation of Marketing Authorization Application for Bylvay® for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (July 7, 2023)
6.
BioMarin Pharmaceutical Announces MHRA Validation of Marketing Authorization Application for Palynziq® for the Treatment of Phenylketonuria (PKU) (June 15, 2023)
7.
Ipsen Announces MHRA Validation of Marketing Authorization Application for Cabometyx® (cabozantinib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) (May 24, 2023)
8.
Jazz Pharmaceuticals Announces MHRA Validation of Marketing Authorization Application for Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for the Treatment of Idiopathic Hypersomnia (IH) (April 12, 2023)
9.
UCB Announces MHRA Validation of Marketing Authorization Application for Bimzelx® (bimekizumab) for the Treatment of Moderate to Severe Plaque Psoriasis (March 8, 2023)
10.
Vifor Pharma Announces MHRA Validation of Marketing Authorization Application for Veltassa® (patiromer) for the Treatment of Hyperkalemia (February 1, 2023)
11.
PTC Therapeutics Announces MHRA Validation of Marketing Authorization Application for Upstaza® (eladocagene exuparvovec) for the Treatment of AADC Deficiency (January 4, 2023)
12.
Neurocrine Biosciences Announces MHRA Validation of Marketing Authorization Application for INGREZZA® (valbenazine) Capsules for the Treatment of Tardive Dyskinesia in Adult Patients (December 7, 2022)
13.
Astellas Pharma Inc. Announces MHRA Validation of Marketing Authorization Application for Xospata® (gilteritinib) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation (November 10, 2022)
14.
AstraZeneca PLC Announces MHRA Validation of Marketing Authorization Application for Imfinzi® (durvalumab) for the Treatment of Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) after Concurrent Chemoradiation Therapy (October 17, 2022)
15.
Bristol Myers Squibb Announces MHRA Validation of Marketing Authorization Application for Breyanzi® (lisocabtagene maraleucel) for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (September 20, 2022)
16.
Gilead Sciences Announces MHRA Validation of Marketing Authorization Application for Trodelvy® (sacituzumab govitecan-hziy) for the Treatment of Metastatic Triple-Negative Breast Cancer (TNBC) (August 16, 2022)
17.
Pfizer Inc. Announces MHRA Validation of Marketing Authorization Application for Lorbrena® (lorlatinib) f2022or the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (July 5, 2022)
18.
Merck & Co., Inc. Announces MHRA Validation of Marketing Authorization Application for Keytruda® (pembrolizumab) for the Treatment of Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors (June 13, )
Oh boy, then you can tell me the names of every leprechaun, unicorn and space alien you talk to.
lol. Bang up job BP doing with their own version of DC for GBM — not.
You are the wolf. Let’s just be clear:
Acceptance
1. Creates a timeline upon which stakeholders, hospitals, neurosurgeons, patients, governments can prioritize preparation.
2. Starts the 150 day or 210 day clock. It does not start without it.
3. Submission shows NWBO and their consultants believe they are ready for review, but acceptance shows the MHRA is ready to review. It is an external source. Dr. Ashkan believes it is a fair and expeditious arbiter.
Very funny. Instead, it’s the big guys that likely sat on NWBO until CI profits squeezed out and patent cliff approaching. You’re doing a heck of a job.
Anybody wants to know why Ex is all wet on his combo take, read LP’s ASM comments on pursuing financially beneficial combos followed by “active discussion” in 10q filings.
Biologic protection from biosimilars is 10 to 12 years.
That you misinform.
That validation/acceptance is not immediate.
No one cares what your friends tell you.
The 150 day clock to an approval decision does not start until validation/acceptance occurs. https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
As even Hoffman points out, this is not an immediate process. The typical number of days for validation are pointed out here.
https://assets.publishing.service.gov.uk/media/657c8aaf95bf65000d7190d3/MHRA-Performance-Metrics_2301-2311.pdf
CRSPR apparently took 36 days to validate. Validation times have gone down considerably since then. Most completed in less than two weeks, excluding holiday vacations.
You mean 8 months and 16 months ago. Not two to three years ago. But who’s counting.
Both are emails. The first one to Branster, the Second one to me.
On Apr 12, 2023, at 3:12 PM, xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx wrote:
Dave
Can you comment on whether NWBO will PR the submission of the MAA or wait to PR once MAA is accepted ?
Seems to be a lot of confusion about that, and I would like to clear that up if possible.
response
I do not see why. We announced the PIP which was just a step along the way. Would it not make sense that we would announce submitting the application which would be considered a milestone.
D
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
Bard Google
The MHRA does not have specific regulations or rules explicitly prohibiting or allowing companies to announce the validation of their MAA submissions.
Bard Google.
There are no specific regulations or rules from the MHRA that explicitly allow or prevent companies from announcing the validation of their Marketing Authorization Application (MAA) submissions.
ChatGPT
The MHRA (Medicines and Healthcare products Regulatory Agency) generally doesn't prohibit companies from announcing the validation of Marketing Authorization Applications (MAAs).
Vertex-and-CRISPR-Therapeutics-Announce-MHRA-Marketing Authorisation Application Validation for CRISPR/Cas9 Gene-Edited
Published: February 6, 2023
https://www.technologynetworks.com/genomics/product-news/vertex-and-crispr-therapeutics-announce-mhra-marketing-authorisation-application-validation-for-369926
Under your logic, they would not announce approval. Dave put NWBO’s position in writing. It was that if they announced something as small as PIP, well of course they’d announce major milestones like submission and acceptance/validation.
LP, Dr. Ashkan and others have been clear they want the world to know this is likely coming with sufficient specificity so that people start learning protocol, like proper tumor preservation. So that infrastructure is set up.
He answered in the affirmative.
I gave his answer to Branster several times as well showing what he meant. Aka, if NWBO announced something as small as PIP, well then of course they’d announce submission and acceptance/validation.
Here’s what BB wants. No transparency so that another silent period for several months, to which we had many, can crush this company down to pennies again until approval for bargain buyers (or possibly shorts), because most other people will assume, due to silence, that the submission did not get accepted to one degree or another, even if it did.
Let’s be clear, BB’s position is that validation was complete without review on December 20. He’s 100% full of B.S.. So he lied, and 40 profiles applauded the lie, because most of them hope for one more opportunity to buy really cheap, many after doing tax sales at the end of the year.
Instead, what they are supporting is months of silence by the company, even after successful validation, and ignoring what Dave Innes stated he would do once acceptance/validation occurred. They’d rather force cheap shares than inform patients, the community, health care facilities, infrastructure, neurosurgeons , patients and the investors with sufficient time specificity to prepare for commercial approval.
In the UK, up to this time, Dr. Ashkan has performed the lion’s share of DCVax-l protocol, at limited sites, which entails proper tumor preservation and connected infrastructure for the therapy to be utilized collected, transported both directions and administered.
After approval, all UK neurosurgeons will need to be ready.
These aren’t pills. One should not unleash a new therapy and protocol on a country without time points leading up to it.
Dave understood this, that’s why he didn’t flinch when asked.
It does matter if DCs are administered intradermally versus other forms of administration.
It does matter if DCs are administered at 1.25 x 10 to the 6th versus ten to the seventh. Avoidance of dc crowding matters.
These things matter.
It matters less if you inject them in a toe or a shoulder. Either way, they’ll still get to the lymph nodes.
I wasn’t standing, now go take a powder.
I’m not agreeing or disagreeing with you, but for more DD, my recollection is that in the past few months, Advent hired some tech transfer people.
Many years ago Cognate did the same thing to help Advent get up to speed.
CRSPR applied with MHRA first than FDA a few months later. Then, months later, CRSPR was approved by the MHRA and a few weeks later by the FDA.
Or, you are intentionally ignorant, “bright boy,” and think MAAs are completely validated at the exact time of submission, and try to boss everyone into thinking this. You shoved aside Dave Innes comments as if they don’t matter. You disrespect the need of stakeholders and the health industry to be informed of timelines and get prepared to help patients.
ChatGPT versus Hoffman
Publicly disclosing the validation or acceptance of a marketing authorization application by the MHRA can bring transparency to the regulatory process. This disclosure builds trust by demonstrating that the submission has met initial regulatory requirements, potentially instilling confidence in the product or company. It also provides stakeholders, including patients, healthcare professionals, and investors, with essential information about the progress of the regulatory review, which can be crucial for making informed decisions or preparing for potential market availability. Additionally, it sets clear expectations and timelines for when the product might become available, aiding in planning and anticipation within the healthcare industry.
Dave Innes versus Hoffman’s Googling
branster
Re: None
Wednesday, 04/12/2023 8:06:45 PM
I just want to clarify with DI on PR Submission vs PR on Acceptance.
I am sure most already believed PR on submission, but just wanted clarification from DI
On Apr 12, 2023, at 3:12 PM, xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx wrote:
Dave
Can you comment on whether NWBO will PR the submission of the MAA or wait to PR once MAA is accepted ?
Seems to be a lot of confusion about that, and I would like to clear that up if possible.
response
”I do not see why. We announced the PIP which was just a step along the way. Would it not make sense that we would announce submitting the application which would be considered a milestone.”
D
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
Flashback: November 19, 2023: Dr. Ashkan
So obviously the next step is to get this drug approved in the UK, where it seems a bit simpler, more efficient pathway to approval which is good news, and we are trying to get the drug approved first in the UK and then beyond that we can move on to the US’s FDA, ect., and so as we speak we are preparing submissions to the MHRA, which is the UK version of the FDA, for regulatory approval and hopefully in the next few months we will hear back. So that was a very quick statement, thank you very much
LC, do you think DCVax-l will be accepted/validated within the required 30 (or less) day review period from date of submission?
flipper44
RE: dennisdave Post # 660731
01/02/2024 11:01 AM
Post
# of 660950
The 16 patient phase 1 Diakonos trial doesn’t start DC treatment until seven months after surgery. Even then, the patient
must be not expected to receive any steroids in the future. There was never any blinding in patient selection. The trial has only been going for two years.
DCVax-l has orphan designation for GBM, but it will also have more general (any indication) biologic exclusive use for 10 to 12 years after first (likely) approval for GBM.
flipper44
RE: abeta Post # 660684
01/02/2024 03:33 AM
Post
# of 660949
In that Meso trial, Merck’s collaborators used subcutaneous injection, which is inferior to intradermal. (Note: DCVax-l is injected intradermally) (Extra note: It looks like Merck is working its way up to a DC dose that will cause crowding)
Note: MESOVAX was the name of the trial, not the product.
Methods
MESOVAX is a Ph1b study evaluating safety of P 200 mg Q3W and an autologous DCvax administered subcutaneously Q3W for a maximum of 6 cycles, in pretreated metastatic M patients (pts). Primary endpoint was safety; secondary were PD-L1 expression variations defined by immunohistochemistry (IHC) and efficacy (objective response rate [ORR], duration of response [DOR], progression-free survival [PFS], overall survival [OS]).
branster
Re: None
Wednesday, 04/12/2023 8:06:45 PM
I just want to clarify with DI on PR Submission vs PR on Acceptance.
I am sure most already believed PR on submission, but just wanted clarification from DI
On Apr 12, 2023, at 3:12 PM, xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx wrote:
Dave
Can you comment on whether NWBO will PR the submission of the MAA or wait to PR once MAA is accepted ?
Seems to be a lot of confusion about that, and I would like to clear that up if possible.
response
I do not see why. We announced the PIP which was just a step along the way. Would it not make sense that we would announce submitting the application which would be considered a milestone.
D
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
branster
Re: None
Wednesday, 04/12/2023 8:06:45 PM
I just want to clarify with DI on PR Submission vs PR on Acceptance.
I am sure most already believed PR on submission, but just wanted clarification from DI
On Apr 12, 2023, at 3:12 PM, xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx wrote:
branster
Re: None
Wednesday, 04/12/2023 8:06:45 PM
I just want to clarify with DI on PR Submission vs PR on Acceptance.
I am sure most already believed PR on submission, but just wanted clarification from DI
On Apr 12, 2023, at 3:12 PM, xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx wrote:
Dave
Can you comment on whether NWBO will PR the submission of the MAA or wait to PR once MAA is accepted ?
Seems to be a lot of confusion about that, and I would like to clear that up if possible.
response
I do not see why. We announced the PIP which was just a step along the way. Would it not make sense that we would announce submitting the application which would be considered a milestone.
D
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
Right. I won’t repeat myself.
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
No doubt NWBO tried to deal with both sides.
1. They hope to receive 150 day accelerated review,
2. They know it may involve a clock stop.
That seemed fair.
David Innes represents NWBO, not ACME
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”
David Innes August 16, 2022
Re: Does NWBO intend to inform the public when it’s MAA is accepted?
“That would be a milestone”