Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Thanks. BTW, Dynavax announced today that the 2013 Novartis Prize for Basic Immunology has been awarded to Dr. Robert L. Coffman, Chief Scientific Officer of Dynavax, and his former collaborator Dr. Tim R. Mossman for their groundbreaking research defining subsets of immune system T cells that advanced the understanding of infectious, autoimmune and allergic diseases.
Lots of possibilities, here. They could do a ROW for the EU to raise cash. And as I've pointed out in a Comment under another article on SA, they already have $50 million available through an ATM put in place in May, 2013. I'm sure Eddie Gray & Staff are working through every possible scenario.
That said, I would be very surprised if the company were forced by the FDA to do another Phase 3 trial. The issue is not efficacy, but rather, the need for additional safety data. (Note, by the way, the FDA has NOT said Heplisav is not safe...only that more data are needed.) For this reason, I tend to believe the trial to be run will be similar to the open-label, single-arm (no comparator) Phase 2 trial previously conducted by DVAX for Hep-B, only enlisting more patients covering a more representative racial spectrum.
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
You may be correct, but there's also the possibility the number required could be on the order of 6,000, or so, with only a single-arm Safety trial required. On the conference call June 10, Eddie Gray noted that the FDA VRBPAC's acknowledged a strong endorsement of HEPLISAV's demonstrated immunogenicity. In addition, Gray also noted the additional safety data collected would facilitate review for an indication in adults 18-70 years of age. So, we know the data collected almost certainly would be for the Hep B indication only.
The key will be to administer Heplisav to the requisite racial profile so as to respond to the concerns of some VRBPAC members, who felt earlier trials did not treat sufficient numbers of certain races. But if only a Safety trial (basically, an open-label Phase 2 study) is required, it should look something like this, though almost certainly with more centers to accommodate the need to enlist a larger number of patients sooner:
"This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by ocurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity."
So, it's possible the company could work its way through this requirement in 2 years, as I have earlier postulated.
By the way, the FDA does have a vested interest in seeing best-in-class treatments brought to bear on hard-to-treat populations, so there is this consideration to keep in mind as well. The fact is, one could test 20,000 patients over 5 years and still not incure THE ONE adverse effect some think might incur. It's the nature of the beast...which is the reason the FDA supported the company's original plan to perform a Phase 4 post-approval study (it's discussed in the advisory committee's briefing material, as you know). It was that study from which you took your patient number above.
As to additional funding, the company recently entered into an At Market Issuance Sales Agreement, or sales agreement, with MLV& Co. LLC, or MLV for $50,000,000.
An Interview With Elemer Piros: A Strong Year For Biotechs, Looking From The Halfway Point [View article]
You are correct.
Actually, the cost of Provenge is a little over $94,000 for three treatments on weeks 0, 2, and 4 (that is, three treatments over a period of one month)). The data I have indicate reimbursement from Medicare is taking place in 30 days or less, and sometimes, in as little as 2 weeks. The fact it, reimbursement to physicians hasn't been a concern for well over a year. The statement in the article above is a red herring...totally incorrect.
Finally, JNJ recently increased their price for Zytiga, bringing it closer to that of Xtandi (the latter is about $7,500 per month, or $90,000 per year). Prior to the increase, Zytiga cost roughly $80,000 per year (not including the required co-administered prednisone and monthly blood tests to monitor liver functions). Because both Zytiga and Xtandi are reimbursed under Medicare Part D (which does NOT apply to Provenge), both Zytiga and Xtandi can end up costing patients more in terms of out-of-pocket expenses than can Provenge.
Dynavax: FDA Asks For Additional Safety Data [View article]
Hi, Michael...
I don't know about being an 'authority,' but I'll try to respond.
The path forward is for the company to meet again with the FDA (which could happen in the next 2 weeks) to frame the nature of protocols for the trial to be conducted for the purpose of collecting additional safety data. Paramount to the discussion will be whether or not it's a single-arm study (that is, is this a trial without a comparator arm (Heplisav, only)), how many patients will be enlisted (I would hope the trial could be limited to 3,000 patients), the racial make-up of these patients, whether the patients' disease indication is limited to Hep B, and so forth.
Once these matters are resolved, of course, the trial protocols would be finalized and published on the FDA's Clinical Trials Web site, and enlistment begun.
How burdensome the FDA's requirements are will determine how the market reacts. The key, I think, will be the number of patients required because that will determine the trial's time and cost.
And yes...it's unfortunate the FDA could not find some way to accommodate this clearly superior treatment for Hep B and CKD. Again, it was the agency, itself, that asked DVAX to expand the BLA to include the 18-70 age group, and the FDA's own briefing documents pointed to approval with a Phase 4 (post-approval) study. The treatment was shown to be as safe as GSK's treatment. Frankly, the racial makeup arguments spouted by some on the advisory committee were red herrings, in my opinion, and I have concerns as to how much Dr. Daum dominated the proceedings.
As for entry, I would wait until we have a better understanding of the terms agreed upon by the company and the FDA regarding the safety study to be performed.
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
dmjsa113...
Yes, there are several law firms seeking a lead plantiff in this matter. Even if they find one, I doubt the case will proceed. The FDA itself recommended that DVAX expand the label during BLA submission, and the agency's briefing documents pointed to approval with a post-approval (Phase 4) trial to gather additional data. (I assume you have read the briefing documents. As well, did you read the transcript of the advisory committee meeting?) It was the actions of an allegedly conflicted advisory committee chairperson of the FDA's choosing that threw everything in a cocked hat. The company could hardly be found complicit in such actions.
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Daum's CV was corrected, after Sen. Grassley inquired, to show his GSK grant support was only for the year 2002. His GSK consulting work (as best that can be determined...the record is incomplete because companies were not compelled to report monies paid until this year) was for the year 2009. Still, the subject of his COIs came up again in Ed Silverman's Pharmalot article yesterday (Monday):
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Having read the Phase 3 trial results and the FDA briefing materials as well as monitoring the advisory committee proceedings, I don't think it would have made any difference what indication the company sought...it was pretty clear Dr. Daum, the chairperson, had a burr under his saddle vis-a-vis safety, and he was bound and determined to drive that message home...which he did, swaying enough of the other members on the committee to swing the vote his way. He 'front-end loaded' the attack by his comments at the end of the discussion of the preceeding question, and then, when moving on to the question on safety, launched into what eventually turned a positive meeting into a disaster. Frankly, my opinion is the man should have recused himself from the meeting...entirely! The fact he consulted for GSK as late as 2009 (as well as having taken grant money from them earlier) raises some interesting questions. (By the way, it's not possible, given the lack of reporting requirements, to know if he consulted for GSK subsequent to 2009; beginning in 2013, I believe, the reporting requirements are stricter. Others and I just happened to stumble on the 2009 report of his payment.)
For more 'color' on the interaction earlier this month between the company and the FDA (which appears to have been very positive), listen to today's presentation:
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
http://bit.ly/16gsbg1
This company has some significant technology under patent that would make it a good target for an acquirer.
Ted
Dynavax: A Takeover Target? [View article]
That said, I would be very surprised if the company were forced by the FDA to do another Phase 3 trial. The issue is not efficacy, but rather, the need for additional safety data. (Note, by the way, the FDA has NOT said Heplisav is not safe...only that more data are needed.) For this reason, I tend to believe the trial to be run will be similar to the open-label, single-arm (no comparator) Phase 2 trial previously conducted by DVAX for Hep-B, only enlisting more patients covering a more representative racial spectrum.
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
http://bit.ly/11mpVnA
The key will be to administer Heplisav to the requisite racial profile so as to respond to the concerns of some VRBPAC members, who felt earlier trials did not treat sufficient numbers of certain races. But if only a Safety trial (basically, an open-label Phase 2 study) is required, it should look something like this, though almost certainly with more centers to accommodate the need to enlist a larger number of patients sooner:
http://1.usa.gov/11mpTvM
"This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by ocurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity."
So, it's possible the company could work its way through this requirement in 2 years, as I have earlier postulated.
By the way, the FDA does have a vested interest in seeing best-in-class treatments brought to bear on hard-to-treat populations, so there is this consideration to keep in mind as well. The fact is, one could test 20,000 patients over 5 years and still not incure THE ONE adverse effect some think might incur. It's the nature of the beast...which is the reason the FDA supported the company's original plan to perform a Phase 4 post-approval study (it's discussed in the advisory committee's briefing material, as you know). It was that study from which you took your patient number above.
As to additional funding, the company recently entered into an At Market Issuance Sales Agreement, or sales agreement, with MLV& Co. LLC, or MLV for $50,000,000.
http://bit.ly/11mpTvO
These funds would be raised at any time without a formal offering.
Ted
An Interview With Elemer Piros: A Strong Year For Biotechs, Looking From The Halfway Point [View article]
Actually, the cost of Provenge is a little over $94,000 for three treatments on weeks 0, 2, and 4 (that is, three treatments over a period of one month)). The data I have indicate reimbursement from Medicare is taking place in 30 days or less, and sometimes, in as little as 2 weeks. The fact it, reimbursement to physicians hasn't been a concern for well over a year. The statement in the article above is a red herring...totally incorrect.
Finally, JNJ recently increased their price for Zytiga, bringing it closer to that of Xtandi (the latter is about $7,500 per month, or $90,000 per year). Prior to the increase, Zytiga cost roughly $80,000 per year (not including the required co-administered prednisone and monthly blood tests to monitor liver functions). Because both Zytiga and Xtandi are reimbursed under Medicare Part D (which does NOT apply to Provenge), both Zytiga and Xtandi can end up costing patients more in terms of out-of-pocket expenses than can Provenge.
Ted
Amgen's And Vical's Melanoma Trials: Questions [View article]
I'm looking into the target event rate possibilities now.
If and when I have something, will publish here first.
Ted
Dynavax: FDA Asks For Additional Safety Data [View article]
Be well.
Ted
Dynavax: FDA Asks For Additional Safety Data [View article]
I don't know about being an 'authority,' but I'll try to respond.
The path forward is for the company to meet again with the FDA (which could happen in the next 2 weeks) to frame the nature of protocols for the trial to be conducted for the purpose of collecting additional safety data. Paramount to the discussion will be whether or not it's a single-arm study (that is, is this a trial without a comparator arm (Heplisav, only)), how many patients will be enlisted (I would hope the trial could be limited to 3,000 patients), the racial make-up of these patients, whether the patients' disease indication is limited to Hep B, and so forth.
Once these matters are resolved, of course, the trial protocols would be finalized and published on the FDA's Clinical Trials Web site, and enlistment begun.
How burdensome the FDA's requirements are will determine how the market reacts. The key, I think, will be the number of patients required because that will determine the trial's time and cost.
And yes...it's unfortunate the FDA could not find some way to accommodate this clearly superior treatment for Hep B and CKD. Again, it was the agency, itself, that asked DVAX to expand the BLA to include the 18-70 age group, and the FDA's own briefing documents pointed to approval with a Phase 4 (post-approval) study. The treatment was shown to be as safe as GSK's treatment. Frankly, the racial makeup arguments spouted by some on the advisory committee were red herrings, in my opinion, and I have concerns as to how much Dr. Daum dominated the proceedings.
As for entry, I would wait until we have a better understanding of the terms agreed upon by the company and the FDA regarding the safety study to be performed.
I hope this helps.
Have a great Father's Day.
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Yes, there are several law firms seeking a lead plantiff in this matter. Even if they find one, I doubt the case will proceed. The FDA itself recommended that DVAX expand the label during BLA submission, and the agency's briefing documents pointed to approval with a post-approval (Phase 4) trial to gather additional data. (I assume you have read the briefing documents. As well, did you read the transcript of the advisory committee meeting?) It was the actions of an allegedly conflicted advisory committee chairperson of the FDA's choosing that threw everything in a cocked hat. The company could hardly be found complicit in such actions.
Amgen's And Vical's Melanoma Trials: Questions [View article]
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
http://bit.ly/108xMGx
As best I can determine, DVAX met with the FDA last week.
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Good material.
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
Ted
Dynavax Technologies - DVAX And Nothing But DVAX [View article]
For more 'color' on the interaction earlier this month between the company and the FDA (which appears to have been very positive), listen to today's presentation:
http://bit.ly/12jj5AE
Ted
Dynavax: FDA Asks For Additional Safety Data [View article]
William Blair's 33rd Annual Growth Stock Conference
http://bit.ly/12jj5AE
Amgen's And Vical's Melanoma Trials: Questions [View article]
BTW, the Phase 3 Allovectin trial enrolled January 2007-February 2010 with 390 patients: 260 in the treatment arm, and 130 in the chemo arm.