 Thank you, Mr. Chairperson. Good morning all. I'm representing MSF OCB Mumbai, the project on HIV, DRTB and Hep-C co-infected patients. Study is aptly titled as Too Little Too Late. Just to break down the alphabet jargon, starting with the drug-susceptible tuberculosis, which responds to all the treatment, standard treatment, easy to treat, six to nine months of treatment is required. We go further down the line, multidrug resistant tuberculosis that is resistant to isoniazid and rifampicin. Further down the line, pre-XDR tuberculosis, pre-extensive drug-resistant tuberculosis that is in addition to isoniazid and rifampicin, it is resistant to either a fluoroquinolone or an aminoglycoside, but not to both. And extensive drug-resistant tuberculosis, XDRTB, which is HR fluoroquinolone and one of the aminoglycosides to be resistant. Further down the line, we have unspecified drug-resistant tuberculosis patterns, which have no name as of now. People call them XXDR, TDR. So any patient can present as a drug-susceptible tuberculosis and can progress with failing each line. Or they can be primary MDR or primary XDR. There are multiple factors for drug-resistant tuberculosis. So the scenario, which as a part of a DRTB community, which we are facing right now, it's quite challenging. More and more difficult to treat drug-resistant patterns are emerging. It usually takes longer to treat. Use of toxic drugs are required and basically the clinical, there is no trial backing the clinical, there's no trial backing the evidence we have to treat the patient. There are fewer drugs to treat. Usually we have to reach the magic number of four or more, which we are finding it difficult. And when it comes to treating the cure rates with drug-resistant tuberculosis, the cure rates are slightly dismal. When it comes to MDR globally, the cure rate is 48%. And it drops down further to 38%. And HIV, DRTB go infected patients. With enough of complaining that the last decade has been exciting for us, we have several new diagnostic tools with rapid turnaround time after a gap of almost 100 years, if not more. Renewed interest, there is a renewed interest in TB research. Reanimation of age old forgotten tools, that is surgery and pulmonary tuberculosis. And after a gap of almost 40 to 50 years, since the last TB drug revamp, we have two new drugs. The new drugs are bedaculine and the laminate. They were given accelerated up clearance by WHO in 2012 and 2013, respectively, for conditional use and with monitoring and pharmacovigilance. Bedaculine is currently registered in nine after 27 countries, or the 27 high burden countries. In India, conditional access program has started. And the main problem with these drugs right now apart from access is the high cost. Bedaculine per course is priced at 900 US dollars and laminate is somewhere around projected to be 1700 US dollars. While enough time to rejoice, the sad part is only 2% of the patients who actually need the drug have access to it. Coming to our clinic, MSF Clinic in Mumbai, we provide free drug resistant tuberculosis and HIV treatment services since 2006. So far we have 1101 HIV and 253 TB DRTB beneficiaries. As you can see in the diagram, we are concentrating more and more on the severe patterns of drug resistant tuberculosis, mainly pre-XDR and XDR. We have had access to bedaculine through compassionate use program since 2013 till August 2015, when the compassionate use program was closed. We have access to laminate since June 2015. Prior to introduction of any of the drug, there was extensive counseling and consent required because of a black box warning of death and cardiotoxicity to these drugs. Also, we have to protect the drug from becoming resistance and spread of resistance to these drugs in the population. Also, these drugs were never introduced alone. It's a descriptive study from routinely recorded and collected medical data, retrospective cohort analysis of 12 patients registered for bedaculine and 14 patients for laminate from FEP 2013 to December 2015. Numbers might be small, but our patients on laminate constitute 10% of the global cohort of total laminate use so far outside clinical trials. So both these drugs are only issued for adults. We have had two HIV-coinfected patients in the bedaculine group and almost 75 to 80% of patients in both the groups were XDR tuberculosis. And most of the patients have had exposure to second line anti-tubic drugs. The main cause of concern here is there were two patients who were never exposed to second line anti-tubic drugs and they were highly unfortunately to get primary XDR tuberculosis. Coming to a concept called likely effective drug, which is we are literally defined as drugs either sensitive on a DST result or less than three months of exposure to the drug. So most of our patients, approximately 80% of our patients have two or less than two number of likely effective drugs working for them. 12 patients were registered on bedaculine, compassionate use. One died prior to initiation, 11 was started on treatment, one died after the bedaculine course was completed. Two patients in bedaculine arm have completed their 24 months and rest are doing well on treatment. In the laminate arm, 14 patients were enrolled. One died prior to initiation of the tuberculosis treatment. For one patient, it was extremely sad that we could not form an effective regimen and patient was denied. 12 patients were then started on treatment. Two died and the rest are doing well. Coming to major serious adverse events, there was one death in bedaculine as I told you before. It was after completion of the bedaculine course. Two patients had severe cardiotoxicity with each of the new drugs and there were two other severe adverse events noted in the laminate group. These were the same patients who had severe cardiotoxicity of QTC of more than 500 milliseconds on the ECG. There were three deaths reported, mainly these deaths were due to evolution of drug resistant tuberculosis and there was no direct relationship with the new drugs. When it comes to cardiotoxicity, there was no need for us to permanently discontinue the drug and this was despite of the fact that most of our patients were on other cardiotoxic drugs like moxifluxes and ankylophazamine. We have had promising outcomes. There was sustained culture conversion in 16 out of 18 cases. There is these new drugs are safe for ambulatory treatment with adequate monitoring including clinical lab and ECG monitoring. The limitations of this study, it was a small cohort but mind you it was one of the first ever documented cohort with a high proportion of two or less than two likely working drugs versus the magic number of four which is required for forming an effective regimen. What we have learned is most of our patients had prior exposure to second line drugs. For these patients at least two new drugs are required to establish an efficient treatment. Too few drugs are available and they are diagnosed too late. When it comes to the access to these drugs which is long, tedious and arduous patients died before initiating the treatment. Compassionate use program for delaminated is quite restrictive and stringent while due to the conditional access program that has started in India, the compassionate use program for bedakulin has been cut down in the entire country. To conclude, use of new TB drugs should be scaled up not to be preserved as a last chance of multiple failures. Two new drugs is not effective in DRTB management. We need urgent there is an urgent need for broader access to bedakulin and delaminated combination for patients with two or less than two likely working drugs. There is a need for larger trial data with new regimens not just adding new single molecules also these trials they had excluded the pediatric patients, pregnant females, lactating mothers and also we feel that there was a misrepresentation of HIV co-infected patients with drug resistant tuberculosis in the trial. Also remember that we had two patients who were primarily XDR. We need to tackle the ongoing transmission in the community which is the thing we are facing in Mumbai more and more nowadays. In the end, I would like to acknowledge the MSF team from Mumbai and Delhi and our patients who ended their difficult life journey with DRTB to have access to these new drugs. Thank you.