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From what I understand the goal is to add to the shelf. I assume it would require a vote. Hopefully we will have some value before a major financing to minimize the downside for current holders.
It does not, according to Les.
Thx. Just waiting impatiently, LOL.
I cannot speak for anyone else but your argument just made me feel more comfortable with my investment. For anyone who has the slightest knowledge of the biology of GBM it will hopefully do the same.
Hey guys,
There are a lit of drugs that have been FDA approved but are not going to have NICE review over a year later. Some even longer than a year. If you do a little digging you can find them. I am nit to concerned about England. I am focusing right now on the pub and topline. If good things will fall into place here then things may change there.
Examples to look ip:
Binatumomab
Durvalumab
Hope you are right because looks like the volume has dried up.
Thx. You got that right. If we get rewarded financially for this. I think we earned it.
My concern as well. I cannot argue your point. The plan has been several PR's in succession. Do they have anything up their sleeve? That depends on what you believe and if you still believe in management. That is a personal choice.
21 million at a buck, then a little later 9 million at a buck. A good amount of cash.
Pretty happy today with the L presentation. Happy overall to see that they are so close to the end of trial. Obviously, sorry for those in the trial. I hate though thinking of the many more patients who are being denied access of what is I believe is an effective treatment. I have inferred from the data that there will most likely be a significant long tail survival. I think that number will be in the 30% range and could be over 30 months. I have always felt that will be enough to get approval. The enroolment chart also gives hope for quite an impressive median overall survival. That assumption on my part from what we were given today can be argued by those who don't believe in the therapy. I personally discussed with the company the need to at least know the full enrollment date, number enrolled, exact number of patients alive, and rough enrollment numbers so investors would have at least a crude way to model the study and gage chances of success. I had this discussion with them about a month ago. I am also very pleased with the clarification of PFS and OS being independant endpoints in the trial along with other secondary endpoints. This was a point which has been discussed to the point of nausea. I feel the verdict is in the favor of longs.
I have my concerns. Finances are a mess to say the least. I really feel the warrants that expire in a few weeks would be a dagger to the shorts. If they are exercised there will most definitely be enough money to see L to the finish line. I personally don't feel that D should be a priority at this time. Many will disagree with me. That is fine. The presentation on D today was not exactly exciting from a shareholder perspective. I don't think the purpose of that trial was to accomplish that. Phase 2 should be much different and more definitive.
I am hopeful they have some sort of plan to get the price up enough to get the June warrants exercised. Even if at a 50% discount. I believe it can make all the difference for a lot of longs. Though I think it should, the information given today will most likely not be enough to turn the tide. It does have the potential to be great fuel once the price is jump started and today's talk is dissected more. There were a lot if hints given out today.
This is all of course IMHO.
I did get killed pretty bad. If something could be done I would be on board. I don't post much because I don't think there is too much to say anymore. Results will dictate outcome. Obviously not the case in the short term while we wait. Because the trial is far enough along that bankruptcy is not even a thought to me. As far as long as we are in the trial, if that was to happen(I do strongly doubt it) they would simply just have to unblind the trial and see where they are at. I feel we are getting pretty close to a safe zone if not already there in terms of some sort of success. It is hard to say anything for sure because we don't really have recruitment times. I have been able to thankfully average down, and if the stock does modestly well, I will be more than grateful from a financial standpoint. I do hope to be involved in the D trials down the road and I have spoken with Linda about that. It is just a little tricky since I am heavily invested. We decided to talk again when things are a little more clear with L. Anyways, just staying low until we know one way or the other. GLTA who want to see success.
Does anybody know how many unexercised warrants are out there now?
Hey Sentiment, I have been off the board for a bit. I am having a hard time following what you and Abeta were discussing with enrollment numbers and dates. Would you mind posting the bottom line what you are coming up with when it comes to enrollment numbers and dates in a form a kid like me could understand?:)
For those concerned about the crossover. I just talked to an old med school friend of mine whose husband is recovering after treatment for Leukemia. He is now in remission. He has been offered to be in a double blinded trial. He would either get placed on Opdivo or placebo. They also have a crossover just like DCVax phase 3. If the disease recurs while on placebo he has the option to start Opdivo at that time. I guess we are ahead of the curve on that one.
Agreed. What information that they gave out in the last 8k's could not have been given out 15 months ago? I don't see any way it at all could have compromised this trial. That was just basic information that is on most companies 10Q's. Read Argos last one they just spell everything out so clearly. Problem is I like this science more.
Just finished an email exchange with my daughters 3rd grade teacher. Her husband of less than a year just had a glioblastoma removed and is recovering. I had recommended she get a consult at UCLA. She said she just saw Dr. Cloughesy at UCLA and they are waiting on pathology. Hope he is able to get DCVax. This guy cannot be more than his early 30's. This trial has got to finish. I am getting the feeling a lot more people will suffer waiting than people will benefit by waiting for a few more events in this trial. They need to find a happy median.
I don't know if this was posted already. If it was, sorry. I just read it and it explains things very well. It appears from reading this there may be a lot going on in England. I sense that things could move a lot quicker than we originally thought. I am going to read it again right now but I wanted to give some others a chance to read it as well and chime in. I may be reading into things to positively.
https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/eams-process-jan-16.pdf
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
CENTRE FOR HEALTH TECHNOLOGY EVALUATION
Note to describe procedures at NICE to support the Early Access to Medicines Scheme
Introduction to the Early Access to Medicines Scheme
1. In April 2014, the Government announced the launch of the Early Access to Medicines Scheme (EAMS). EAMS provides an opportunity for important drugs to be used in UK clinical practice in parallel with the later stages of the regulatory process. It is anticipated that medicines with a positive EAMS opinion could be made available to patients 12-18 months before formal marketing authorisation.
2. Under the scheme, the Secretary of State for Health, acting through the Medicines and Healthcare products Regulatory Agency (MHRA) issues a scientific opinion on the benefits and risks of a new medicine or indication. This opinion provides additional information for clinicians and patients to assist in treatment decisions in areas of unmet medical need.
Key stages of EAMS and NICE’s role in them
3.
The following paragraphs outline the key stages of EAMS and NICE’s role in them.
i. Promising Innovative Medicines (PIM) designation and NICE Topic Selection – A PIM designation gives an early signal that, based on the evidence to date, the medicine may be a possible candidate for the Early Access to Medicines Scheme and thus has the potential to be of value in areas of unmet medical need. The MHRA operates the process resulting in a PIM designation.
EAMS – procedures at NICE
January 2016
1
Companies signal their intention to apply for a PIM designation and EAMS at an early stage by completing the relevant fields in UK PharmaScan. The MHRA advises NICE of the award of a PIM designation, subject to this information being treated as commercial in confidence unless and until the information is made public or otherwise disclosed by the company.
When NICE becomes aware of a PIM designation, the topic progresses through the usual NICE Topic Selection process (unless the technology is already covered in existing NICE guidance or is not within NICE’s remit, for example a vaccine), except that products with a PIM designation are prioritised.
ii. Joint scientific advice – A PIM designation may be granted to products at an early stage in clinical development. It is strongly recommended that companies which receive a PIM designation seek joint scientific advice. This gives companies an opportunity to meet with both NICE and the MHRA to discuss their development plans at length from both a HTA and a regulatory perspective, and then to receive a bespoke written advice report addressing key questions. NICE Scientific Advice is offered on a not-for- profit fee-for-service basis.
iii. Pre-submission meeting (MHRA) – The MHRA holds one pre-submission meeting to ensure that all the information they need to reach an EAMS opinion is available before a company formally submits evidence for an EAMS opinion.
iv. NICE EAMS meeting – The NICE Office for Market Access offers companies the opportunity to have a supplementary meeting with NICE to discuss the company’s data collection plans during the EAMS period, in order to help ensure the company is well prepared for a potential Technology Appraisal (TA) or Highly Specialised Technologies (HST) evaluation. In some cases, data on clinical and cost effectiveness may
EAMS – procedures at NICE
January 2016
2
need to be generated during the EAMS period to address the uncertainties in the clinical effectiveness evidence or anticipated resource use. These data will inform any subsequent submission to NICE. The NICE EAMS meeting aims to help companies gain insight into the NICE processes and evaluation frameworks, as well as to learn more about the option to develop and propose managed access arrangements and patient access schemes to support adoption following the EAMS period and NICE appraisal.
NICE EAMS meetings are optional and offered on a fee-for-service, not-for- profit basis. It should be noted that NICE EAMS meetings are not a substitute for joint NICE and MHRA scientific advice, where much more detailed engagement on prospective clinical development plans is offered.
In planning for the EAMS period, including potential additional evidence generation, an arrangement between the company and NHS England will be necessary. NHS England is invited to the NICE EAMS meeting to discuss the necessary arrangements.
If a ministerial referral to NICE has already been made for the topic, a company may consider the standard TA decision problem meeting to be a sufficient forum to discuss plans for their submission to NICE, particularly if further evidence generation is unlikely to be feasible at this late stage. The decision problem meeting is a standard part of the NICE TA and HST processes and no charge is made for this meeting. A company may however believe that further evidence generation during the EAMS period would be both meaningful and feasible, and may ask for a separate NICE EAMS meeting.
Detailed procedures for NICE EAMS meetings are in the appendix.
v. Positive EAMS opinion – This is granted by the MHRA and is expected towards the end of the development process (typically at the end of phase
EAMS – procedures at NICE
January 2016
3
III trials). It can exceptionally happen earlier. The EAMS opinion enables prescribers and patients to decide if the product might be suitable for an individual patient. Products with a positive EAMS opinion could be available to NHS patients 12-18 months before marketing authorisation is granted. The MHRA expect that EAMS products will be provided by the company to the NHS free of charge during this period.
vi. EAMS period and NICE TA or HST evaluation – NICE anticipates that before the EAMS period starts, all EAMS products will already have been selected as topics for a NICE TA or HST evaluation.
In order to develop timely guidance, NICE starts the TA or HST evaluation during the EAMS period (before marketing authorisation), and the company prepares its submission during this period. Any data collected during the EAMS period may be included in the company submission.
A NICE TA or HST evaluation of an EAMS product follows the normal published processes and methods. If NICE is notified of the PIM designation and positive EAMS opinion at least 12 months before expected receipt of marketing authorisation, these products are planned as a priority into the work programme so as to allow the first Committee decision to be published within 3 months of marketing authorisation, rather than 6 months under the usual process.
Prioritising EAMS products for evaluation may have the effect of deprioritising other products if there are late changes in the regulatory timelines for the EAMS product.
vii. Marketing authorisation and NICE TA or HST evaluation recommendations – In line with standard processes, NICE issues preliminary recommendations for public consultation or final recommendations (where there are no issues requiring public consultation) as soon as possible after marketing authorisation.
EAMS – procedures at NICE
January 2016
4
If the Appraisal Committee or HST Evaluation Committee agrees that the product can be recommended, these recommendations are subject to the 2013 Regulations. These provide for a legal duty for NHS England, clinical commissioning groups and local authorities to make treatments recommended by NICE available to patients. The regulations normally require that products recommended by NICE are commissioned within 3 months of publication of the guidance. NHS England reduces this to 30 days for EAMS products.
4. The components of the EAMS process are outlined in Figure 1.
Authors:
Meindert Boysen, Elisabeth George & Jenniffer Prescott - Technology Appraisals Fay McCracken & Nick Crabb - Office for Market Access
Issue date: January 2016 Review date: June 2016
EAMS – procedures at NICE
January 2016
5
I spoke with him about that in the recent past. No intention of a reverse split. The goal has been to have an investor to take on the debt with interest. He has mentioned another financing is possible so we may see that. I do not think it will be nearly as dilutional as the last one as long as the debt can be dealt with(which he had some confidence it would). We will see about that. I also believe there are several pieces of news that can be put out over the next several weeks that could make any financing of very little consequence to long term holders who have had a harder time averaging down. We will see.
May your words be true:) This marathon needs to end.
Interesting. We know the FDA/regulators have seen all of the data from the L trial. That means that the MHRA has as well most likely seen it. I would guess the MHRA has recommended a review by NICE based on that data. At least I hope so.
Senti, read my last post. Interesting if I am right and very bullish.
Why is the expected publication date Febuary of 2018? It is at the top. Does that mean we won't hear for quite a while? What is interesting is that the on this page on the bottom is a date of the last update which was in July of last year. Could they have actually moved up the date to January of this year? They seem to be reviewing it now. If they did move it up I would take that as a very positive sign.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
Yes there could be. He said whatever it takes to get to the finsh line.
If that is true, must mean they are going back to them for financing. Also means there is not even competition rigjt now for toxic financing. That stinks.
When I last spoke with Les I specifically asked this question. There were around 305 or 306 patients enrolled and being treated at the time of the screening halt. The rest were in the pipeline and enrolled after the screening halt in August. I don't know the date that the last patient was actually enrolled but would guess most at 3 is no issues and no more than 4 months after this considering risk of post op complications. He made that very clear to me. I was pressing him that day with some pretty hard questions.
I did, no answe yet.
I have written Linda an email thanking her for some of the clarity she has given us with the trial. I also asked if it would be possible for her to PR the date which they hit the PFS threshold. I am assuming it was within the past few months but more clarity would further hurt the bear argument. Hopefully she responds.
I would hope to see other information come out soon like the reason for screening halt, investigation results, NICE decision, BMY and unknown combination trial announcement. These things could lead to progressive share price rise while we wait. Information arm update would be nice too.
He said June/July
I do speak with Les about once a month. I can tell you that I check the consistency of my conversations with other people I have gotten to know quite well offline and I trust. People who speak to Les regularly. He clearly said one data lock after OS has hit it's endpoint. This is consistent with what 3 other shareholders have told me. I hope they have a trick up there sleeve or they change their minds. I want AA.
One other kind of simple point about being granted AA. How could they have been granted it in the past if they were not ready to manufacture enough vaccine? It appears now they are. The ability to show this could have been one of the things the FDA was waiting on along with some of the PFS and OS theories that have been discussed.
It makes the most sense to me, but I am sick of being punched in the gut Nice to know you are thinking the same thing though:)
It is funny Dr. Black said he was not aware of any trial that had these kinds of results. He worked at UCLA when I was a fellow in surgical oncology. He is fully aware of what DCVax can do. He was there for like 10 years. I doubt he would be so into vaccine research if he did not believe it. It just shows you like I have said before how vicious the competition is among these institutions. It is not always about the patients like you would hope. These institutions bad mouth each other like you would not believe. It is one of the things I hate about academic medicine.
They run clinical trials as well, not with DCVax
Dr. Kieth Black is at Cedar Sinia in Beverly Hills. He trained at UCLA and is a big competitor of UCLA now. He runs his own lab there. He does not use DCVax, it is his own vaccine. He has not had the success that Linda has had in research. He is a very engaging personality and excellent surgeon. Being at Cedars he gets a lot of press locally.
Question I have is if they have hit 248 PFS then those charts must have been reviewed. I don't see why they would anounce that if they were not sure. If what I am saying is true and they have reached statistical significance, why should we not hear about applying for AA very shortly? I agree with those who believe in AA with confimation trial for OS.
From what I understand with my discussions with management is the company is blinded to trial data but the regulators/FDA have seen it all. AA just makes most sense to me.
It has definitely been less than a year because the Act IV study officially failed in March of last year.
OK. The people I have access to talk to tell me he is not the chair of the DSMB anymore. I choose to believe my contacts. Sorry about before, I should not have said "with "FDA". I think Highwayman got my point though.
I am mad at myself, I am disapointed in management to an extent. I don't think they are bad people. Actually just the oppisite. My belief in the science is not shakable. Please give us answers soon.
He is not with the FDA anymore. I think he is now a professor at Wake Foresr University.