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Post by JHam on Aug 1, 2018 17:08:59 GMT
selluwud, I am curious if your daughter would agree with the results from this survey conducted by Life Sci advisors. From Life Sci market study: www.lifescicapital.com/analysis/physician-survey-community-acquired-bacterial-pneumonia/"We conducted a survey on prescribing habits for community-acquired bacterial pneumonia (CABP) in order to better understand the existing unmet needs in the space, current treatment paradigms, and response to updated FDA guidance on the use of fluoroquinolones. We surveyed 120 healthcare professionals, including 34 emergency medicine specialists (EMR), 28 infectious disease specialists (INF), 26 hospitalists (HOS), 16 primary care providers (PCP), and 16 nurse practitioners (NP). AnalystDavid Sherman, Ph.D. (AC)■ Key Results from the Survey. Below are the most important findings from our analysis of the survey data:◦ Need for Oral Drugs Targeting Drug-Resistant Pathogens – This was most frequently cited—by 43% of physicians—as thebiggest unmet need in CABP.◦ Most Important Features in Selecting an Antibiotic – The physicians cited the importance of an antibiotic being well-tolerated,having an IV-to-oral step-down, and having a low propensity to cause C. difficile infections.◦ Fluoroquinolone Use is Expected to Decrease in CABP – 56% of surveyed physicians expected to prescribe fluoroquinolonesfor CABP less often following the updated FDA guidance earlier this year.◦ Focus on Lowering Treatment Costs – Lower cost of therapy and reducing hospital stays, a major driver of treatment cost, werecommonly cited as pressing unmet needs in CABP.◦ Empiric Treatment is Standard Practice in CABP – The surveyed physicians performed cultures only roughly 40% of the timein CABP patients, highlighting the importance of empiric treatment options.Best in class? Let's take 4 important antibiotic attributes:Broad Spectrum MonotherapyIV to oral optionOnce DailyFavorable Safety and Tolerability"OMD possesses all four attributes. Penicillins, TMP-SMX and Cephalosporins possess two of these attributes (IV to oral and Favorable Safety and Tolerability). Macrolides possess three attributes (IV to oral, Once Daily, and Favorable Safety and Tolerability). Fluoroquinlones possess three attributes (all of them except Favorable Safety and Tolerability). I will see my daughter this evening and I will bring up this survey and see if falls within her everyday working knowledge. She's pretty sharp, her specialty is transitional care, reviewing prescribed drug guidelines with patients being released from the hospital. Insurance companies put the cost of care back on the hospitals if patients are readmitted within 30 days for the same conditions they were admitted for originally. Her documented consultations give proof that a patients failure to follow the self care dosage directions can put the cost back on the patient. Health insurance is going to be the straw that breaks the camel's back eventually. Wow, very cool. You must be very proud Thanks for doing that, but no worries if you are busy with family time. Thanks though!
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Post by JHam on Aug 1, 2018 17:15:13 GMT
New SA article just out. In terms of the lack of run-up to the Adcom meeting, it seems that due to so much bad luck recently with new antibiotic drugs getting, and since some patients experienced vomiting in the oral trial, that many may are taking the see-it-to-believe-it approach. Fearing they will give it a black label warning or in the worst case not approve. I still feel that some of the risk is mitigated since we are essentially trading at cash level: seekingalpha.com/article/4192947-add-paratek-pharmaceuticals-adcom-meeting-biotech-catalyst-calendar
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Post by selluwud on Aug 2, 2018 1:14:43 GMT
selluwud, I am curious if your daughter would agree with the results from this survey conducted by Life Sci advisors. From Life Sci market study: www.lifescicapital.com/analysis/physician-survey-community-acquired-bacterial-pneumonia/"We conducted a survey on prescribing habits for community-acquired bacterial pneumonia (CABP) in order to better understand the existing unmet needs in the space, current treatment paradigms, and response to updated FDA guidance on the use of fluoroquinolones. We surveyed 120 healthcare professionals, including 34 emergency medicine specialists (EMR), 28 infectious disease specialists (INF), 26 hospitalists (HOS), 16 primary care providers (PCP), and 16 nurse practitioners (NP). AnalystDavid Sherman, Ph.D. (AC)■ Key Results from the Survey. Below are the most important findings from our analysis of the survey data:◦ Need for Oral Drugs Targeting Drug-Resistant Pathogens – This was most frequently cited—by 43% of physicians—as thebiggest unmet need in CABP.◦ Most Important Features in Selecting an Antibiotic – The physicians cited the importance of an antibiotic being well-tolerated,having an IV-to-oral step-down, and having a low propensity to cause C. difficile infections.◦ Fluoroquinolone Use is Expected to Decrease in CABP – 56% of surveyed physicians expected to prescribe fluoroquinolonesfor CABP less often following the updated FDA guidance earlier this year.◦ Focus on Lowering Treatment Costs – Lower cost of therapy and reducing hospital stays, a major driver of treatment cost, werecommonly cited as pressing unmet needs in CABP.◦ Empiric Treatment is Standard Practice in CABP – The surveyed physicians performed cultures only roughly 40% of the timein CABP patients, highlighting the importance of empiric treatment options.Best in class? Let's take 4 important antibiotic attributes:Broad Spectrum MonotherapyIV to oral optionOnce DailyFavorable Safety and Tolerability"OMD possesses all four attributes. Penicillins, TMP-SMX and Cephalosporins possess two of these attributes (IV to oral and Favorable Safety and Tolerability). Macrolides possess three attributes (IV to oral, Once Daily, and Favorable Safety and Tolerability). Fluoroquinlones possess three attributes (all of them except Favorable Safety and Tolerability). I will see my daughter this evening and I will bring up this survey and see if falls within her everyday working knowledge. She's pretty sharp, her specialty is transitional care, reviewing prescribed drug guidelines with patients being released from the hospital. Insurance companies put the cost of care back on the hospitals if patients are readmitted within 30 days for the same conditions they were admitted for originally. Her documented consultations give proof that a patients failure to follow the self care dosage directions can put the cost back on the patient. Health insurance is going to be the straw that breaks the camel's back eventually. Ok, I talked to the brains in the family and from what I could understand between all of her work vernacular and pharmacy jargon, unless this drug was groundbreaking and way better than what's available (which it doesn't seem to be) she said her healthcare system would not add it to their formulary. I can think of a couple of things that are working against a good revenue stream; one, there are generics available at costs savings which are getting the job done, secondly, without a major sales force that a Pfizer or big pharma has established, going it alone is going to be a long hard road. As far as the survey bullet points, she agrees with most of what was in the listed results with some slight disagreements about something that she said was contradictory. I didn't ask her to dumb it down for me and missed her exact assessment. I'm hoping for the Advisory Committee's positive recommendation and hopefully enough of a price spike to bail out with some profit based on her doubts about this drug becoming mainstream first choice.
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Post by JHam on Aug 2, 2018 3:42:40 GMT
I will see my daughter this evening and I will bring up this survey and see if falls within her everyday working knowledge. She's pretty sharp, her specialty is transitional care, reviewing prescribed drug guidelines with patients being released from the hospital. Insurance companies put the cost of care back on the hospitals if patients are readmitted within 30 days for the same conditions they were admitted for originally. Her documented consultations give proof that a patients failure to follow the self care dosage directions can put the cost back on the patient. Health insurance is going to be the straw that breaks the camel's back eventually. Ok, I talked to the brains in the family and from what I could understand between all of her work vernacular and pharmacy jargon, unless this drug was groundbreaking and way better than what's available (which it doesn't seem to be) she said her healthcare system would not add it to their formulary. I can think of a couple of things that are working against a good revenue stream; one, there are generics available at costs savings which are getting the job done, secondly, without a major sales force that a Pfizer or big pharma has established, going it alone is going to be a long hard road. As far as the survey bullet points, she agrees with most of what was in the listed results with some slight disagreements about something that she said was contradictory. I didn't ask her to dumb it down for me and missed her exact assessment. I'm hoping for the Advisory Committee's positive recommendation and hopefully enough of a price spike to bail out with some profit based on her doubts about this drug becoming mainstream first choice. selluwud, Thanks for asking her, and please thank her for looking over that and giving her opinion! Her response falls pretty much in line with the bears sentiment. After reading a lot about this over the last few days here is what I have concluded: Pros- Omadacycline is more or less equally efficacious (was shown to be not inferior) than the current Abx on the market - A few advantages are that it is a once daily formulation (as opposed to twice daily), that has a favorable safety record, broad spectrum, and can treat the Big 3 indications. And it has shown strong efficacy results against antiobiotic-resistant bacteria Cons- While trials showed a favorable safety record, the oral dose did cause vomiting in 16.8% of patients.** - As your daughter says, through combination of currently available generic antibiotics, patients can get a similar result to Omadacycline at a fraction of the cost... - ...Therefore a $500M drug may not have a place in the space at the moment - It is very tough to have a successful launch/penetrate the market without big pharma support (as your daughter mentioned). **Incidentally, the oral-only trial was added at the last minute as a back up in case the IV trial failed. It wasn't originally intended to be part of the treatment. It ended up showing overall improved efficacy at the expense of some mild side effects in 16.8% of patients. So it will be interesting to see what the FDA thinks about this. IV approval only? IV and oral both approved with a black label warning for oral? IV and oral both approved without any barriers? Again, assuming that it gets approved, the success of the drug will come down to pricing in my opinion. As John Tucker (a scientist who doesn't think there is a market for OMD) said: While I may prefer the special sauce in a Big Mac, if it costs $500 I'd be perfectly happy to settle for a $1 Whopper. They could royally screw this up in several ways, but I still feel that a new, safe, efficacious antibiotic that can treat multiple indications - plus their other antibiotic for acne, Sarecycline, (which has a PDUFA date in October as well), are ultimately worth more than the current market cap. Then you add the cash on top of that and I still feel relatively comfortable giving them a shot at commercialization. Of course if they don't get approved or recommended for approval then I would not stick around. This next week will determine how I go about things. They have an earnings call tomorrow afternoon at 4:30pm which should be interesting. phx.corporate-ir.net/phoenix.zhtml?c=253770&p=irol-newsArticle&ID=2359398
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Post by JHam on Aug 3, 2018 7:08:53 GMT
Just listened to the call. In summary as it relates to the issues we've discussed here, management acknowledges those issues but clearly believes Omadacycline is different and will be a successful money maker in the future. Of course they are going to say that, but I understand their logic behind it. Here are some highlights: seekingalpha.com/article/4194181-paratek-pharmaceuticals-inc-prtk-ceo-michael-bigham-q2-2018-results-earnings-call-transcript?part=singleAdam Woodrow - Chief Commercial Officer & VPThanks, Mike. Progress continues to be significant across the commercial organization in preparation for our Q1 2019 launch. As a reminder, we plan to initially launch omadacycline in the hospital setting with the potential for broader opportunity in the community market beyond year 2. Our market access plan remains on track with the hiring of our national account management team, our NAMs, and key account management team, our KAMs. These teams have been conducting extensive meetings with P&T members and other formulary decision makers within our targeted geographies and key accounts. This includes several large and national payers as well as select by the end with our NAM and KAM teams, respectively.
We have also had several meetings with important federal accounts, such as Veteran Affairs, Indian Health Services and the Department of Defense. These meetings are designed to keep the payers and hospital systems well informed about omadacycline and prepared for early P&T review of omadacycline once approved. We believe these activities have the potential to facilitate earlier adoption. Our pricing research is ongoing, and we plan to have the results of that research closer to approval. We expect our official price will be publicly communicated in the fourth quarter of this year.
Now during Q3, we anticipate the onboarding of our sales force leadership team. We expect to start hiring our hospital representatives in Q4 and will continue through 2019 toward our target of 80 to 85, which we believe is sufficient to address approximately 800 -- in 850 of the key U.S. hospital accounts.
In recent advisory board meetings with health care professionals, the feedback suggests omadacycline has the potential to fulfill an important unmet medical need in the marketplace. Our market continues to highlight the need for safe and effective options, particularly those with a convenient IV that can potentially minimize hospital and/or eliminate hospital admissions altogether. Because resistance represents a critical concern in the infectious disease space, we are excited about the potential for omadacycline to address this ever-growing unmet medical need, especially when one considers the growing list of safety warnings for the fluoroquinolone cost of antibiotics, specifically, recent addition of mental health side effects and serious blood sugar to the existing black box warnings.
As with all antibiotic launches, we modest uptake of omadacycline over the first year or two as we gain institutional access. It is customary with new antibiotics for hospitals to pursue a trial and adoption approach. That being said, we see significant long-term commercial potential for our once-daily IV and oral antibiotic, which we believe proven to be efficacious, safe and well-tolerated. We look forward to providing periodic update progress in the months ahead.///// Ami FadiaCan you walk through any of the recent work you may have done with respect to pricing dynamics in the market and also around sort of physician advantage? You mentioned that you would expect sort of taking the initial 1 or 2 years to be somewhat sort of slow. Could you talk through whether this is related to the need to build physician advantage? Or is it more due to just gaining the bare access? Adam Woodrow - Chief Commercial Officer & VPThanks for the question. So look, our pricing research is ongoing. And as I mentioned earlier on, we're going to have that to hand a bit closer to the approval time. And actually, we'll make that official prior to our launch in Q4. We appreciate that the prices for an access to treatment is a chief concern to the patients, providers, payers and policymakers. But we know that we provide a great value with an IV, oral that can minimize hospitalization when in fact, in some cases, avoid hospitalization altogether. I mentioned the fact that anti-infectives have a slow uptake. It's actually due -- in large part, due to the fact that again, hospital formulary or availability of institutions before you can actually generate demand. That does take time. It's not something that happens literally overnight. Our plan, obviously, is in between the approval and launch to try and minimize some of that by making sure that the awareness of the drug is in place and that some of that education is done around the basics in advance of the actual representatives hitting the road when the drug is actually available.///// Adnan ButtMaybe one on the CAP indication. How important indication overall for Paratek? And then, let's say, the FDA were commencing at this time, is the company capable of another CAP study?Adam Woodrow - Chief Commercial Officer & VPSo I'll take the first part of that in terms of the CAP indication. We -- look, we've got two indications that we're submitting, and we believe that we'll be approved for both. The CAP data is strong evidence, presented that at length. And we know that the benefit risk here is compelling. I should point out that seen a new IV, oral broad-spectrum agent in maybe and so the need for new CAP agent is <this is incomplete on the transcript> In terms of where it fits from a financial perspective, I think I've been quite consistent in the fact that, as I've said before, whilst the skin market is -- seems to be saturated, it doesn't actually have very good IV, oral broad-spectrum agents in the skin space. Both skin and CAP form a significant chunk of projections in terms of where our revenue is going to come from. [Indiscernible] I'd tell you that they're not too far apart from each other in terms how much the spread is between the two. Both of those indications are significant.
///// Robert HazlettOkay. And I'd love to do a follow-up. Just a quick one on the strategic landscape for antibiotics. A number of large pharma have decided that they don't really want to participate. That could create some strategic scenarios. I know you're right on the precipice of important seminal events for omadacycline. That said, assuming success, how do you think about the current strategic landscape? And are -- is broader participation beyond omadacycline something that might be under consideration down the road?Michael Bigham - Chairman & CEOThanks, Bert, Mike Bigham. Yes, noticed obviously that Novartis, after some period of time, elected to leave the space. And obviously, we don't know what their specific reasons were for their decision. And so in general, prefer to have them remain in this space unless, of course, they had competing products, which they did not. The challenges in the antibiotic space are well-understood, but that does not diminish the acute and growing need for new treatment options, as you're well aware. And the level of investment and innovation is falling behind the active pace at which bacteria develop resistance. And obviously, if this process persists, a day of reckoning is inevitable. But even today, effective, safe, generally well-tolerated new antibiotic treatment option, like omadacycline, still represents significant commercial potential.
And obviously, we remain excited to be the stewards of this promising new antibiotic, and we still believe that omadacycline has the potential to be a franchise product for Paratek. In terms of looking at other antibiotics in this space, it's part of our overall pipeline development strategy. We're evaluating other antibiotics, which obviously could make an awful lot of sense strategically for us. But if, frankly, you have to look at each product on a case-by-case basis, if we look at what unmet medical need it's addressing, what the profile of other product is from both an efficacy, a safety and tolerability standpoint. And there's no shortcut to doing that homework. So yes, as a class, we're interested. We look. But on a case-by-case basis, we have to get excited about the agent that we're looking and assess its commercial potential. And if it meets our criteria, then we're prepared to add that to our quiver.
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Post by JHam on Aug 4, 2018 2:42:52 GMT
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Post by JHam on Aug 6, 2018 12:48:22 GMT
Questions are out. Only two and fairly straight forward: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM615843.pdfFOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Antimicrobial Drugs Advisory Committee (AMDAC) Meeting FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503) 10903 New Hampshire Avenue, Silver Spring, Maryland August 08, 2018 DRAFT QUESTIONS ______________________________________________________________________________ 1. VOTE: Has the applicant provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections? a. If yes, please provide any recommendations concerning labeling. b. If no, what additional studies/analyses are needed?
2. VOTE: Has the applicant provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia? a. If yes, please provide any recommendations concerning labeling. b. If no, what additional studies/analyses are needed?
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Post by JHam on Aug 6, 2018 13:27:27 GMT
finance.yahoo.com/news/paratek-antibiotic-not-inferior-current-125859408.htmlParatek antibiotic not inferior to current treatments-FDA staffReuters Reuters•August 6, 2018 Aug 6 (Reuters) - A new antibiotic from Paratek Pharmaceuticals Inc is not inferior to current treatments for bacterial skin infections and pneumonia, U.S. Food and Drug Administration staff reviewers said on Monday. The comments come two days ahead of an advisory committee meeting that will evaluate the safety and effectiveness of the drug, omadacycline. The company's shares rose 2 percent to $10 before the bell. However, FDA staff flagged safety concerns observed in the trial testing omadacycline as a treatment for community acquired bacterial pneumonia.
"Of concern is the imbalance in mortality ... This mortality imbalance in a randomized controlled trial is noteworthy," staffers said
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM615848.pdf. There has been a push to develop new antibiotics as the United States faces growing concerns over resistance to current antibiotic treatments. At least 2 million people become infected annually with bacteria that do not respond to treatment with existing drugs, according to the Centers for Disease Control and Prevention. (Reporting by Tamara Mathias in Bengaluru; Additional reporting by Manas Mishra)
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Post by JHam on Aug 6, 2018 13:33:30 GMT
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM615848.pdf. The treatment groups were balanced regarding key baseline factors, PORT scores, prior antibacterial therapy, and other baseline disease characteristics and risk factors for poor prognosis or mortality in CABP. Of concern is the imbalance in mortality seen in the CABP trial. An etiology for the imbalance could not be determined from the available current data. Although the rate of mortality in the omadacycline group appears to be similar to the 30-day mortality observed in recently conducted CABP trials, this mortality imbalance in a randomized controlled trial is noteworthy. No significant differences in adverse events, SAEs or adverse events leading to treatment discontinuations were seen between treatment groups in the CABP trial.
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Post by selluwud on Aug 6, 2018 13:46:52 GMT
All I did was give my trading agents two trade fees, I'm out, nothing lost, nothing gained. Good luck in the long run.
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Post by JHam on Aug 6, 2018 13:52:50 GMT
All I did was give my trading agents two trade fees, I'm out, nothing lost, nothing gained. Good luck in the long run. So long old friend The more I read of this report, the more it looks pretty good. I feel little more at ease regarding safety concerns of the ABSSSI oral only trial tripping up approval. They don't seem to raise too much concern over it. The most common adverse reactions that occurred at a notably higher frequency in the omadacycline treatment group were nausea and vomiting in ABSSSI trials, especially in Study ABSI-16301, which was oral only trial. Most adverse reactions were mild to moderate in severity. The most common adverse reactions that led to study drug discontinuations were from the SOC ‘Infection and infestations’ in all Phase 3 trials, and majority of those were worsening of index infection under study (either ABSSSI or CABP). These patients were recorded as treatment failures in the efficacy analyses. Overall, there were no clinically significant adverse event trends in vital signs. Although increased heart rate was observed in healthy volunteers randomized to receive omadacycline, in a thorough QT (TQT) study, heart rate tended to decline over time in both treatment groups in the CABP trial. In the Phase 3 clinical trials, including the CABP trial, routine and random electrocardiograms were performed while the patients were on therapy. A preliminary review of the electrocardiogram data suggests that within the therapeutic exposure level, omadacycline does not raise the risk for arrhythmia.
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Post by selluwud on Aug 6, 2018 13:57:00 GMT
All I did was give my trading agents two trade fees, I'm out, nothing lost, nothing gained. Good luck in the long run. So long old friend The more I read of this report, the more it looks pretty good. I feel little more at ease regarding safety concerns of the ABSSSI oral only trial tripping up approval. They don't seem to raise too much concern over it. The most common adverse reactions that occurred at a notably higher frequency in the omadacycline treatment group were nausea and vomiting in ABSSSI trials, especially in Study ABSI-16301, which was oral only trial. Most adverse reactions were mild to moderate in severity. The most common adverse reactions that led to study drug discontinuations were from the SOC ‘Infection and infestations’ in all Phase 3 trials, and majority of those were worsening of index infection under study (either ABSSSI or CABP). These patients were recorded as treatment failures in the efficacy analyses. Overall, there were no clinically significant adverse event trends in vital signs. Although increased heart rate was observed in healthy volunteers randomized to receive omadacycline, in a thorough QT (TQT) study, heart rate tended to decline over time in both treatment groups in the CABP trial. In the Phase 3 clinical trials, including the CABP trial, routine and random electrocardiograms were performed while the patients were on therapy. A preliminary review of the electrocardiogram data suggests that within the therapeutic exposure level, omadacycline does not raise the risk for arrhythmia.You know now that I'm out, this puppy will sky rocket....hang in there.
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Post by JHam on Aug 6, 2018 14:01:37 GMT
So long old friend The more I read of this report, the more it looks pretty good. I feel little more at ease regarding safety concerns of the ABSSSI oral only trial tripping up approval. They don't seem to raise too much concern over it. The most common adverse reactions that occurred at a notably higher frequency in the omadacycline treatment group were nausea and vomiting in ABSSSI trials, especially in Study ABSI-16301, which was oral only trial. Most adverse reactions were mild to moderate in severity. The most common adverse reactions that led to study drug discontinuations were from the SOC ‘Infection and infestations’ in all Phase 3 trials, and majority of those were worsening of index infection under study (either ABSSSI or CABP). These patients were recorded as treatment failures in the efficacy analyses. Overall, there were no clinically significant adverse event trends in vital signs. Although increased heart rate was observed in healthy volunteers randomized to receive omadacycline, in a thorough QT (TQT) study, heart rate tended to decline over time in both treatment groups in the CABP trial. In the Phase 3 clinical trials, including the CABP trial, routine and random electrocardiograms were performed while the patients were on therapy. A preliminary review of the electrocardiogram data suggests that within the therapeutic exposure level, omadacycline does not raise the risk for arrhythmia.You know now that I'm out, this puppy will sky rocket....hang in there. Scouring over twitter, people who have followed the Abx sector for decades are very upbeat on this news. Up 6% at the moment.
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Post by JHam on Aug 7, 2018 1:35:12 GMT
Nice little run today, touching $11 and closing up almost 12%. If it continues tomorrow I may take some off the table heading into Adcom.
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Post by selluwud on Aug 8, 2018 12:02:52 GMT
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Post by JHam on Aug 8, 2018 12:22:54 GMT
Yeah that is usual for a company during an Adcom meeting.
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Post by JHam on Aug 8, 2018 16:56:46 GMT
Adcom committee votes 17-1 in favor of approval for ABSSSI!
CABP vote next.
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Post by JHam on Aug 8, 2018 17:05:09 GMT
14-4 in favor of approval for CABP!
Some concerns about imbalance of mortality. Possibility for post-approval trial to address that.
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Post by JHam on Aug 8, 2018 17:36:41 GMT
Several Adcom committee members raved about how they believe OMD will be a very important new drug.
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Post by JHam on Aug 8, 2018 17:43:25 GMT
U.S. FDA panel backs approval of Paratek's antibioticfinance.yahoo.com/news/u-fda-panel-backs-approval-171806618.htmlAug 8 (Reuters) - A U.S. Food and Drug Administration expert panel on Wednesday voted in favor of approval of Paratek Pharmaceuticals Inc's antibiotic to treat bacterial pneumonia and skin infections. The panel voted 17-1 in favor of the drug's safety and effectiveness in treating acute bacterial skin and skin structure infections, and voted 14-4 for treating community acquired bacterial pneumonia. The vote comes ahead of a final decision by the FDA on the drug's approval, which is expected by early October. The FDA typically follows the recommendations of its advisory panels, but is not obliged to do so. The drug, omadacycline, would be the first of a new class of antibiotics known as aminomethylcyclines, and could help in countering growing antibiotic resistance. Shares of the company were halted ahead of the panel's vote. (Reporting by Manas Mishra in Bengaluru)
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