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This meeting certainly has bearish consequences. Given the high level FDA'ers present and Amarin's slew of lawyers & execs, I would be willing to bet that FDA rejected NCE and Amarin demanded a meeting to discuss why or lobby harder for it. Tough to spin this positively
I've talked with some about Amarin's patents and they really didnt see them as a huge barrier. Some of Amarin's patents say no DHA, well what if an analytical chemist at Teva finds 0.01%? Also, there is a ton of prior art out there from Epadel for someone to challenge Amarin's patents.
Some head honcho from the FDA at AMRN meeting :
E Dickinson, Esq.; FDA Chief Counsel;
Jay Sitlani, FDA, Regulatory Counsel.
K Webber, FDA Dir of Pharma Sci;
D Esposito, FDA Deputy Director - Office of Regulatory Policy;
E Coleman, FDA Deputy Director, Metabolism Division;
C Rosenbraugh, FDA Director Office of Drug Evaluation II;
K Johnson, FDA, Regulatory Project Manager;
M Unlu, FDA Gen'l Attorney;
K Dettlebach, FDA, Gen'l Attorney;
re: AMRN
This meeting is a little strange so close to the PDUFA date. In searching thru the FDA's site, I couldn't find another example of such a meeting(which date back to 2007).
I suspect the FDA issued something to AMRN earlier and they requested a meeting to clarify. It certainly has a hint of bearishness to it.
http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/default.htm
At least one of us can admit to being wrong. Actually I was correct in my earlier prediction on Onyx that was published, but the briefing docs later had me thrown. Even the AdComm admonished Pazdur/FDA for the flip flop between the docs and their comments at the panel. Anyways, Stick to your gut.
Also, how's Oncothyreon doing? IMO going nowhere fast. Their PI3K seems like a dud....Stimuvax will be on the dud list soon enough.
I found the original ILNS-Wyeth/Elan agreement.
http://sec.gov/Archives/edgar/data/1337905/000114420408030722/v115138_8k.htm
Please stop posting nonsense on this board. The CHMP isnt even scheduled to meet for another 2 weeks.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/chmp_meetings_landing_page.jsp&mid=WC0b01ac0580028c7d
I wonder if OMER is on their radar
A Look Into Some COPD Plays With Pending Catalysts
http://www.chimeraresearchgroup.com/2012/07/a-look-into-some-copd-plays-with-pending-catalysts/
They run a p2 trial in heart attacks and just called it a success with no mention of the endpoints. Sounds like slice and dice to me. OSIR not known for being honest either...
Re GEVA
It's a bet on management, and they're top notch. Can't put a better team together for ultra-rare diseases. Alexion 2.0
Nice to see a biotech deal actually happen vs more rumors. BMY sure on a spending spree. This might force other big pharmas to make a move
What do you think the chances are?
INX189 not dead yet; BMS registered 360 pt INX189/Daclat +/- RBV P2b trial at clinicaltrials.gov yesterday
http://clinicaltrials.gov/ct2/show/NCT01629732?term=INX-08189&rank=7
I disagree
- ANTH is hiding both of the failed arms, so no way to judge the data
- They dont give any N's for the 200mg weekly dose or any subgroups
- " a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (24 weeks, p=0.15) and throughout week 44; including a statistically significant improvement at week 20 versus placebo (p=0.02)"
It wasn't stat sig at any time period except week 20.
Anthera trial FAIL
Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.
The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).
In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI =10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks. In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44. Results from the 200mg weekly group are presented in Table 1.
"The extensive data in the target severe population from our Phase 2 clinical program supports the initiation of a much smaller yet differentiated Phase 3 registration plan with the selected dose of blisibimod in patients with severe systemic lupus erythematosus. We have prospectively demonstrated for the first time the possibility for a subcutaneously administered BAFF inhibitor to be used in the treatment of a severe lupus population. The subgroup of severe patients from our Phase 2 study clearly identifies those patients most in need of therapy and most likely to benefit from our potent BAFF inhibitor blisibimod," said Paul F. Truex, Anthera's President and Chief Executive Officer. "Feedback from the EMA Scientific Advice process combined with an End of Phase 2 meeting in the third quarter will form the basis of our final phase 3 study designs."
http://finance.yahoo.com/news/anthera-updates-phase-3-plans-214000838.html
SNTA: This company is really immature and so are the data. CEO such a big time hype-ster. They should have waited longer. Curious the CEO never mentioned the non-adeno arm of the trial had been terminated until today, but sure did talk up the KRAS/LDH arms. KRAS was not a co primary end point at the start of the study - hence exploratory - changed it to a co-primary at a later date.
PR here
http://ir.syntapharma.com/phoenix.zhtml?c=147988&p=irol-newsArticle&ID=1709755&highlight=
Slides here
http://www.syntapharma.com/Documents/GALAXY_Interim_Data_June_2012.pdf
Some other notes (courtesy of Twitter)
Postmarket studies will include CVOT and 5 pediatric trials; ARNA has to split costs of Pediatric Studies with Eisai
DEA review of Belviq could take 4-6 months; FDA recommends DEA schedule 4 for Belviq.
"Analysts trying to get execs to say when they will conduct a Belviq-phentermine combo study. They're not answering."
$500M in API already manufactured
That's true. I think their sales are going to be very hard to project given how often patients will be on and off the drug.
I have heard some whispers that some docs will likely use it in combo with phentermine or metformin once they get comfortable with the drug. Arena would be smart to do a study here.
ARNA FDA spox confirms no REMS requirement for Belviq
Watch out men, priapism makes the label.
FDA PR here
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm?utm_source=twitterfeed&utm_medium=twitter
ARNA approved , now known as Belviq
--ARNA must conduct 6 post-marketing studies, including a CVOT
-- Belviq labeling says drug should be discontinued in patients who fail to lose 5% of their body weight after 12 weeks
Then how is VVUS Qnexa avoiding JNJ's patents on topamax?
They've said it's tentatively approved, waiting on some pediatric marketing exclusivity to expire but they don't give the date.
SUPN is so full of BS. Notice they dont say when the exclusivity is up.
Seems like it isnt going to be marketable until 2014
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020505&Product_No=001&table1=OB_Rx
Thanks for these slides.
It confirms my suspicion that Lemtrada will be a dark horse to take away sales from many of the leaders(Rebif, Avonex, Copaxone). Did they talk about pricing or hint at priority review?
Really impressive data and truly helps MS patients get away from being defined by the disease(constant injections etc). Good to see that the deaths dont appear related to Lemtrada. Altough anecdotal, there does seem to be a good amount of enthusiasm for the drug via patients/doctors.
FDA meeting minutes from the May 10th AdComm do not put ARNA in a favorable light. Some fun quotes for longs
-- Many panel members indicated that it was a very difficult vote and they reluctantly voted “Yes”
-- Committee Discussion: Many panel members indicated that it was a very difficult vote
and they reluctantly voted “Yes” that the benefits outweigh the risk for treatment of
obesity patients since the magnitude of weight loss was moderate. Several panel members
indicated that valvulopathy should be included in the Risk Evaluation and Mitigation
Strategies (REMS) requirements and as part of the warning in the labeling and major
adverse cardiovascular events (MACE) should be addressed as part of the phase 4 postmarketing cardiovascular trials requirements. Additional studies should be conducted to
explore the issue of prolactin, tumor development, psychiatric effects and possible drugdrug interaction since this drug will probably be used in combination with other drugs.
Echocardiogram should be required at the initiation of therapy and possibly at yearly
physical check up.
-- Committee Discussion: The committee members who voted “No” suggested that the
sponsor should conduct similar studies as those seen in diabetes trials to include a higher
risk population. The population should be composed of two-thirds hypertensive patients
and one-third to one-half diabetics and dyslipidemic patients. In addition, the
valvulopathy study should be extended. Further studies may be needed for the potential
drug-drug interactions with other psychiatric drugs and selective serotonin reuptake
inhibitors (SSRIs). Other suggestions included a REMS requirement, a warning in the
labeling for the potential of valvulopathy, and prescriber training and patient education
regarding the safe and proper use of lorcaserin.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm285142.htm
Looking at where the majority of the study locations are, I would be a little nervous going into this data. About half are in the eastern EU/Russia. This is a bad recipe...
http://clinicaltrials.gov/ct2/show/study/NCT01348126?term=synta&rank=1&show_locs=Y#locn
Sanofi's Lemtrada likely to see strong physician uptake in MS patients with active disease, long-term side-effects on watch – neurologists
2012-06-06 BioPharm Insight
Sanofi's (EPA:SAN) Lemtrada (alemtuzumab) is likely to see strong physician uptake and become the "go-to" treatment for patients with active multiple sclerosis, neurologists said.
The France-based drugmaker recently presented final results of two pivotal Phase III trials CARE-MS I and CARE MS-II. CARE-MS II, comparing the investigational drug alemtuzumab to Merck (ETR:MRK) and Pfizer's (NYSE:PFE) Rebif in patients with relapsing-remitting multiple sclerosis (RRMS) who had relapsed while on prior therapy, announced that co-primary endpoints of the trial were statistically significant.
Consistent with the CARE-MS II results, CARE MS- I showed a benefit on relapse one co-primary endpoint; however, only a trend was shown on the second co-primary endpoint sustained accumulation of disability.
In CARE-MS I, the disability progression for patients in the Rebif group was not as rapid as we had predicted it would be, a spokesperson said. Therefore, while fewer patients in the Lemtrada arm experienced a worsening of disability, the difference between the groups was not significant, he added. Treatment with Lemtrada resulted in 55 % reduction in relapse rate compared to Rebif, he said.
One investigator said Lemtrada will become a "go-to" drug for physicians more and more as they become familiar with it.
Of note and in contrast to patients on interferon-beta, overall disability was improved in Lemtrada patients over two years, said Dr Mathias Buttmann, senior consultant neurologist, University Hospital of Würzburg, Germany. Although by design of CARE-MS II a lot of interferon non-responders were included, which may represent a bias favouring alemtuzumab, these results are very exciting, he said.
Lemtrada has the potential to be the first approved "super potent" MS drug, Dr Stephen Krieger, said assistant professor of neurology, Corinne Goldsmith Dickinson Center for MS, Mount Sinai Medical Center, New York. However, he noted that this will likely be utilized for second- to third-line treatment, as this has been a major unmet need for MS patients with severe disease course that has not been responsive to other agents.
This news service previously reported the drug is likely to be used as a second- or third-line treatment.
It is very likely it will be used in aggressive cases where patients are not responding to treatment, said Dr Jeffery Dunn, clinical associate professor, Neurology & Neurological Sciences, Stanford University, California. The general importance of the drug is that it is very potent, he added.
While CARE-MS I did not demonstrate a significant reduction of disability progression in Lemtrada versus interferon-beta patients, this could possibly be due to the low disease activity already in the interferon group, said Buttmann.
CARE-MS II, which in contrast to CARE-MS I was not conducted in treatment-naive patients but in those experiencing break-through disease activity on ABCR (approved injectable treatments), now demonstrated an impressive difference regarding disability progression, favouring Lemtrada over interferon-beta, Buttman said.
Injectable products approved for MS include Biogen Idec's Avonex, Bayer's (ETR:BAYN) Betaseron, Rebif, Novartis's (VTX:NOVN) Extavia and Teva's (TLV:TEVA) Copaxone.
Taking the Lemtrada clinical trial program as a whole, Lemtrada seems to be the most effective agent available to date for patients with RRMS, although no head-to-head comparisons (e.g. with natalizumab) were performed to be absolutely sure about this, Buttman noted.
Results from CARE-MS I (naive patients) were not as impressive as in CARE-MS II (patients who experienced relapses under first-line treatment i.e. INFb or Copaxone) and so far data are in favour of using Lemtrada as a second-line treatment, Dr Georgios Hadjigeorgiou, associate professor of neurology University of Thessaly, and Elias Zintzaras, associate professor of biomathematics University of Thessaly, said jointly in an email.
There could be issues with the data during the approval process as a first-line treatment as combination therapies have been found to be very promising in MS, Hadjigeorgiou and Zintzaras wrote.
In CARE-MS II, Lemtrada used soon after INFb or Copaxone failure and the question of whether results from CARE-MS II are the result of the usage of consecutive treatments may be asked because this could explain differences between the results of the two trials, Hadjigeorgiou and Zintzaras wrote.
Yet, Dr Joseph Berger, chairman of the University Of Kentucky Department of Neurology, said that his most important concern is often disability, as this can have a considerable and profound effect on quality of life.
The lack of benefit seen on the CARE MS-I trial could be due to the fact that even the control group did not progress much on this measure, said Dr Jai Perumal, assistant professor, Department of Neurology and Neuroscience, Weill Cornell Medical College, New York. She explained that if patients are not progressing very much it is difficult to demonstrate a difference between groups.
Side-effects
The safety profile of Lemtrada is well established, consistent in all in studies, and manageable, the spokesperson said. Both pivotal studies included a risk management program, and we do expect that the FDA will require a REMS program for Lemtrada, as it has for other newer MS treatments, he added.
Autoimmune effects need to be watched with Lemtrada and the very low levels of lymphocytes; however, so far there have not been any instances of "terrible infection." Lemtrada will be used over a short-term duration due to a lack of long-term data, Perumal added.
Five-year data is required in order to fully understand the carcinogenicity potential of the drug, Perumal added.
Lemtrada significantly reduces the number of lymphocytes, and this is why the extension trials will be very important, one neurologist said. Additionally, there has been some carcinogenicity associated seen on the clinical trials to date, he added.
Side-effects of this drug need to be watched very carefully, Dunn said. He added that long-term side-effects such as malignancy could be an issue, he added.
Overall, Lemtrada was safe over a two-year duration in CARE-MS II, Buttmann said, adding that, nevertheless, Lemtrada is a very strong immunosuppressant with unknown long-term adverse effects.
Buttmann said he would place Lemtrada as a third-line treatment in patients with very high disease activity on the general notion that this is a very strong immunosuppressant which might be harmful over a long-term duration (e.g. potential carcinogenicity). However, there is no data on this so far, he added.
Immunogenicity long-term follow-up studies will determine whether the drug is used as a short-term or chronic treatment, Hadjigeorgiou and Zintzaras wrote.
There need to be three to five year follow-up trials conducted to fully understand the risks associated with the drug, Berger said.
What effect do you think Lemtrada will have on the MS market? I could see it impacting Rebif and Avonex sales to some extent.
Oops completely missed that last one related to production had to occur in 2011. Do most still project Lemtrada to have a tough time commercially?
Was this just posted on the courts website?
NLNK had really strong volume today. Stock has been on a tear since a little before ASCO. Investors gambling on immunotherapies
Anyone think any of these milestones will be met for the Genzyme CVR(GCVRZ)? Seems like #1 probably happens. Have they returned Cerezyme and Fabrazyme levels back to normal yet?
http://mobile.bloomberg.com/news/2012-03-08/sanofi-output-of-rare-disease-treatments-is-increasing
The CVR contains 5 discrete milestones related to the development and commercialization of
Lemtrada:
1) Approval Milestone: CVR holders are entitled to receive $1 per CVR after U.S. FDA approval of Lemtrada for treatment of multiple sclerosis, if the approval occurs on or before March 31, 2014.
2) Product Sales Milestone #1: CVR holders are entitled to receive $2 per CVR in the event net sales for Lemtrada total $400 million or more on a global basis during specified periods following product launch.
3) Product Sales Milestone #2: CVR holders are entitled to receive $3 per CVR in the event global net sales for Lemtrada total $1.8 billion during any 4 consecutive calendar quarters. Any quarters used in the achievement of this sales milestone cannot be used again for the achievement of any subsequent milestones. In addition, if this Product Sales Milestone #2 is achieved despite U.S. FDA approval of Lemtrada for treatment of multiple sclerosis not having occurred on or before March 31, 2014 (and so the Approval Milestone Payment was not made), CVR holders will be entitled to receive an additional $1 per CVR for Product Sales Milestone #2.
4) Product Sales Milestone #3: CVR holders are entitled to receive $4 per CVR in the event global net sales for Lemtrada total $2.3 billion during any 4 consecutive calendar quarters. Any quarters used in the achievement of this sales milestone cannot be used again for the achievement of any subsequent milestones.
5) Product Sales Milestone #4: CVR holders are entitled to receive $3 per CVR in the event global net sales for Lemtrada total $2.8 billion during any 4 consecutive calendar quarters.
The CVR also contains a separate milestone related to the production of Cerezyme and Fabrazyme:
1)Production Milestone: CVR holders are entitled to receive $1 per CVR in the event that Cerezyme and Fabrazyme production levels in 2011 hit both of the following thresholds: (a) production of at least 734,600 units of Cerezyme (with each unit measured on a “400 Unit Vial Equivalent” basis) and (b) production of at least 79,000 units of Fabrazyme (with each unit measured on a “35-milligram Vial Equivalent” basis).
http://www.sec.gov/Archives/edgar/data/732485/000095012311017162/b85162exv99waw43.htm
Pretty unreal how deceitful Amylin was to investors and the FDA about this issue. The first couple paragraphs of that review are quite shocking.
US approval for Afinitor in this indication is right around the corner.
It's presumably dead in the EU, unless they decide to pull Shire's orphan drug status which lasts till 2020. Bad news for PLX
Anyone willing to opine on Anthera's upcoming analysis of Blisibimod?
Seems like they found a subset or something worthwhile
They have multiple Ph3 protocols up
http://clinicaltrials.gov/ct2/results?term=blisibimod
From someone I spoke with that is familiar with Bayer/Onyx, there is a considerable amount of bad blood between them because of Regorafenib. So I am a little cautious on Bayer buying them.
They also said that the business development folks at Onyx are quite arrogant/greedy. Theyre looking for something like Takeda paid for Millenium, which I think is out of the question. MLNM had a much bigger pipeline to offer and some serious research/marketing skills.
Yeah a little weird.
Idenix Announces Positive Clinical Data for HCV Drug Candidates IDX184 and IDX719
In an Interim Analysis From an Ongoing Phase IIb Clinical Trial of IDX184, an HCV Nucleotide Inhibitor, 89% of Patients Who Completed an Additional 12 Weeks of Pegylated Interferon Plus Ribavirin Treatment Achieved SVR4; 100% (4/4) in 100 mg Arm and 80% (4/5) in 50 mg Arm
IDX719, an HCV NS5A Inhibitor, Achieves Potent Pan-Genotypic Activity in Three-Day Proof-of-Concept Clinical Trial
Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced results from an ongoing phase IIb study of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV). Of the first cohort of 31 patients enrolled in the study, those who achieved an eRVR (n=18), defined as having undetectable levels of virus at 4 weeks and 12 weeks, were randomized to stop treatment after either an additional 12 weeks (n=9) or 36 weeks (n=9) of PegIFN/RBV. Of the nine patients who completed their 12-week PegIFN/RBV extended treatment phase, 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4). Patients who did not achieve an eRVR automatically entered the 36-week PegIFN/RBV extended treatment phase which is ongoing. To date, the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
"We are encouraged by the initial SVR results from the phase IIb program, which have confirmed previous data showing that IDX184 is a potent nucleotide inhibitor with a profile supporting its potential role as a key component of all-oral direct-acting antiviral (DAA) combination regimens for HCV," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We look forward to initiating interferon-free DAA combination studies in the near term."
IDX184 Phase IIb Study Design
In July 2011, the company initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Response-guided therapy was used to complete an additional 12 or 36 weeks of PegIFN/RBV treatment. Study objectives include safety and tolerability, and antiviral activity endpoints.
IDX719 Proof-of-Concept Clinical Trial Data and Study Design
Idenix also announced today positive data from a three-day proof-of-concept study evaluating IDX719, an NS5A inhibitor, in 64 treatment-naive, genotype 1, 2, 3 or 4 HCV-infected patients. Genotype 1 patients were randomized to receive placebo, 25 mg QD (once-daily), 50 mg QD, 50 mg BID (twice-daily) or 100 mg QD for three days. Genotype 2, 3 or 4 patients were randomized to receive placebo, 50 mg BID or 100 mg QD for three days.
IDX719 was well tolerated with no serious adverse events reported. Treatment with IDX719 exhibited potent pan-genotypic activity across genotypes:
In genotype 1 patients (n=28), mean maximal viral load reductions were 3.2 log10 IU/mL in the 25 mg QD arm, 3.7 log10 IU/mL in the 50 mg QD arm, 3.2 log10 IU/mL in the 50 mg BID arm and 3.5 log10 IU/mL in the 100 mg QD arm.
In genotype 2 patients (n=8), the mean maximal viral load reduction was 2.0 log10 IU/mL in both the 50 mg BID and 100 mg QD dose arms with a greater variability in responses among these patients (range: 0.3 -- 4.1 log10 IU/mL).
The company is currently conducting pharmacokinetic and sequencing analyses to further characterize these results.
In genotype 3 patients (n=8), mean maximal viral load reductions were 3.3 log10 IU/mL in the 50 mg BID arm and 3.4 log10 IU/mL in the 100 mg QD arm.
In genotype 4 patients (n=7), mean maximal viral load reductions were 3.9 log10 IU/mL in the 50 mg BID dose arm and 3.4 log10 IU/mL in the 100 mg QD dose arm.
More detailed findings are expected to be presented at a scientific meeting in the second half of 2012.
"We are pleased to demonstrate the first clinical validation of IDX719 in patients in a multiple-dose study with robust activity across multiple HCV genotypes," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "Given these promising findings, we look forward to initiating a phase II combination study of IDX719 with IDX184 by the end of this year."
ABOUT IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. In the ongoing phase IIb clinical trial, IDX184 has been well tolerated with a side effect profile similar to that of PegIFN/RBV. In the first cohort of 31 patients, at 12 weeks in an intent-to-treat analysis, the complete early virologic response (< 25 IU/mL at 12 weeks) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study. The company completed enrollment of a second cohort of 36 additional patients in May 2012.