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Post by selluwud on Apr 15, 2016 14:49:52 GMT
Recent trading has been bullish. No selloff (yet) after yesterday's positive conference call update. Three month chart shows a bit of a flag pattern. Need to continue consolidation at $1.50ish.... next piece of positive news would then suggest a run to $1.75ish from a technical analysis perspective. Good call here Jim.
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Post by jckrdu on Apr 15, 2016 15:56:57 GMT
Recent trading has been bullish. No selloff (yet) after yesterday's positive conference call update. Three month chart shows a bit of a flag pattern. Need to continue consolidation at $1.50ish.... next piece of positive news would then suggest a run to $1.75ish from a technical analysis perspective. Good call here Jim. Thanks Sell, and congrats all.
I took a little bit off the table after it broke out from that flag and hit my short-term pps target of $1.75, but still have the majority of my position invested... as I think we'll see a bigger move when median overall survival is announced in the next several weeks/months.
Would be nice to get news of a partnership to help fund the upcoming Phase 3. In the meantime, today's volume does suggest that institutions are starting to re-buy, which is good news and should help put the floor in... and enable the uptrend to continue.
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Post by Macgruber on Apr 15, 2016 19:21:02 GMT
Thanks Sell, and congrats all.
I took a little bit off the table after it broke out from that flag and hit my short-term pps target of $1.75, but still have the majority of my position invested... as I think we'll see a bigger move when median overall survival is announced in the next several weeks/months.
Would be nice to get news of a partnership to help fund the upcoming Phase 3. In the meantime, today's volume does suggest that institutions are starting to re-buy, which is good news and should help put the floor in... and enable the uptrend to continue.
Just in time jckrdu. Vivo just sold another 400,000+ shares last week. Still own 2 mil shares or so but tired of seeing these app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=10875811&type=HTML&symbol=MEIP&companyName=MEI+Pharma+Inc.&formType=SC+13D%2FA&dateFiled=2016-04-15
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Post by jckrdu on Apr 15, 2016 23:31:00 GMT
Thanks Sell, and congrats all.
I took a little bit off the table after it broke out from that flag and hit my short-term pps target of $1.75, but still have the majority of my position invested... as I think we'll see a bigger move when median overall survival is announced in the next several weeks/months.
Would be nice to get news of a partnership to help fund the upcoming Phase 3. In the meantime, today's volume does suggest that institutions are starting to re-buy, which is good news and should help put the floor in... and enable the uptrend to continue.
Just in time jckrdu. Vivo just sold another 400,000+ shares last week. Still own 2 mil shares or so but tired of seeing these app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=10875811&type=HTML&symbol=MEIP&companyName=MEI+Pharma+Inc.&formType=SC+13D%2FA&dateFiled=2016-04-15Hey Mac - Saw that. I think all pages of the filings indicate that Vivo is still holding over 4 million shares. Looks like they sold roughly 10% over the past week or so, maybe just taking a little off the table on this recent move higher. I agree its not what I was hoping to see, but I'm not too concerned as there seems to be high demand for the shares. But yeah, they need to take their hand off the sell button.
Looking for good data next week on 4/20, median overall response news in the not too distant future, and hopefully news of a partnership for at least 1 of the 3 programs they're getting ready to start... as I just don't see them doing all those trials by themselves.
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Post by RLC on Apr 20, 2016 12:08:42 GMT
Article: investor.meipharma.com/2016-04-20-MEI-Pharma-Announces-New-Clinical-Data-from-First-in-Human-Study-of-ME-401-A-Next-Generation-Oral-PI3K-Delta-InhibitorPoster: www.meipharma.com/sites/default/files/ME-401%20-%20AACR%202016.pdfSAN DIEGO, April 20, 2016 PRNewswire -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced new clinical data from a first-in-human study of MEI Pharma's investigational drug candidate, ME-401, a next generation oral PI3K delta inhibitor. The data, presented today at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, suggest that ME-401 has an excellent pharmacokinetic (PK) and pharmacodynamic (PD) profile and the potential for an improved therapeutic window compared to other PI3K delta inhibitors, including the approved drug idelalisib (marketed as Zydelig®), with a half-life that supports once-daily dosing. Logo - http: /photos.prnewswire.com/prnh/20140805/133834 A copy of the poster presentation, entitled, "Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Administration to Healthy Volunteers," is now available at www.meipharma.com. "PI3K delta is a class of drugs that has shown great promise in the treatment of B-cell malignancies, but with certain toxicities," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "We believe this provides an opportunity for a next-generation drug that can produce therapeutic responses at a safe, effective dose. Thus far, ME-401 has demonstrated all of the attributes we had hoped to see, including linear PK and on-target activity at very low concentrations. Now the goal of our upcoming Phase Ib study will be to show a large therapeutic window in cancer patients. We expect to dose the first patient in this study by the end of June and look forward to providing an update later this year." The Phase I study was designed to assess the safety and tolerability of ME-401 after single ascending oral doses in healthy volunteers to select the most appropriate dose for further clinical evaluation. The open label study enrolled a total of 15 healthy volunteers in 10, 30, 60, 90 and 150 mg dose levels. ME-401 was well tolerated at all dose levels. One subject experienced two treatment-emergent adverse events that were considered drug-related: pain and headache, graded as mild, after a 60 mg dose. The first-in-human study of ME-401 was conducted using Quotient Clinical's Translational Pharmaceutics® platform, which collected PK PD data immediately after each dose and allowed for real-time decision making and manufacturing between dose groups.
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dave
Junior Member
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Post by dave on Apr 22, 2016 14:50:43 GMT
Sounds like quite a large P1. I'm wondering where they will get the money to cover all their proposed trials. Waiting to see where the money comes from before plunking down anymore cash.
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Post by tatshensini on Apr 22, 2016 17:35:20 GMT
Just took a position of 3800 shares @ $1.51....thanks guys for all you do here.
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Post by selluwud on Apr 22, 2016 18:15:29 GMT
Just took a position of 3800 shares @ $1.51....thanks guys for all you do here. Good luck, I have a very similar position.
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Post by Macgruber on Apr 22, 2016 20:54:03 GMT
Hey Mac - Saw that. I think all pages of the filings indicate that Vivo is still holding over 4 million shares. Looks like they sold roughly 10% over the past week or so, maybe just taking a little off the table on this recent move higher. I agree its not what I was hoping to see, but I'm not too concerned as there seems to be high demand for the shares. But yeah, they need to take their hand off the sell button.
Looking for good data next week on 4/20, median overall response news in the not too distant future, and hopefully news of a partnership for at least 1 of the 3 programs they're getting ready to start... as I just don't see them doing all those trials by themselves. Whoops sorry u were correct on the 4mil shares. Friggin turds sold more this past week though (see link below). I don't understand why this company gets no love! app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=10885621&type=HTML&symbol=MEIP&companyName=MEI+Pharma+Inc.&formType=SC+13D%2FA&dateFiled=2016-04-22
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Post by jckrdu on Apr 23, 2016 16:40:15 GMT
Hey Mac - Saw that. I think all pages of the filings indicate that Vivo is still holding over 4 million shares. Looks like they sold roughly 10% over the past week or so, maybe just taking a little off the table on this recent move higher. I agree its not what I was hoping to see, but I'm not too concerned as there seems to be high demand for the shares. But yeah, they need to take their hand off the sell button.
Looking for good data next week on 4/20, median overall response news in the not too distant future, and hopefully news of a partnership for at least 1 of the 3 programs they're getting ready to start... as I just don't see them doing all those trials by themselves. Whoops sorry u were correct on the 4mil shares. Friggin turds sold more this past week though (see link below). I don't understand why this company gets no love! app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=10885621&type=HTML&symbol=MEIP&companyName=MEI+Pharma+Inc.&formType=SC+13D%2FA&dateFiled=2016-04-22IMO, market wants to know how they intend to pay for the upcoming large (500 patient Phase 3 Prac trial), plus the 2 other new trials starting Q2 this year.
Hopefully, they'll announce positive median overall survival (MOS) for Prac to get the pps higher before raising any capital. That would seem to make the most sense, as raising capital before MOS is announced would make no sense, as they're sitting on $50M cash on the balance sheet and shouldn't be desperate to raise cash before announcing the very positive MOS news.
Partnership news for any of those 3 trials would be great.
They may be working to finalize the Phase 3 Prac trial design with the FDA (SPA would be great) before announcing a partnership. We should be hearing news soon on path forward.
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Post by jckrdu on May 9, 2016 14:29:48 GMT
Added more this morning in the $1.30s.
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dave
Junior Member
Posts: 87
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Post by dave on May 9, 2016 15:40:17 GMT
Is there any chance for AA on this one? I read the study was open label.
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Post by jckrdu on Jun 2, 2016 14:54:47 GMT
MEIP remains my 3rd largest position (behind ADXS and TNXP). It's been consolidating in the $1.40s, and looks to be a little breakout today, most likely based on recent CPXX buyout news (similar therapy for AML) and todays SA article. seekingalpha.com/article/3979392-ideas-next-celator
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Post by jckrdu on Jul 6, 2016 17:17:25 GMT
Still being patient with this one. A little movement today on a big buy order...
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Post by RLC on Aug 1, 2016 12:57:42 GMT
MEI Pharma's Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Chemotherapy investor.meipharma.com/2016-08-01-MEI-Pharmas-Pracinostat-Receives-Breakthrough-Therapy-Designation-from-FDA-for-Treatment-in-Combination-with-Azacitidine-of-Patients-with-Newly-Diagnosed-Acute-Myeloid-Leukemia-Unfit-for-Intensive-ChemotherapySAN DIEGO, Aug. 1, 2016 PRNewswire -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are ≥75 years of age or unfit for intensive chemotherapy. In addition, agreement has been reached with the FDA on the Company's proposed Phase III study design. Logo - http: /photos.prnewswire.com/prnh/20140805/133834 The Breakthrough Therapy Designation is supported by data from a Phase II study of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML, not candidates for induction chemotherapy, which showed a median overall survival of 19.1 months and a complete response (CR) rate of 42% (21 of 50 patients). These data compare favorably to a Phase III study of azacitidine (AZA-AML-0011), which showed a median overall survival of 10.4 months with azacitidine alone and a CR rate of 19.5% in a similar patient population. The combination of Pracinostat and azacitidine was generally well tolerated, with no unexpected toxicities. The most common grade 3 4 treatment-emergent adverse events included febrile neutropenia, thrombocytopenia, anemia and fatigue. "This designation speaks to both the serious unmet need for AML patients unfit to receive intensive chemotherapy and the promise of Pracinostat to address this need," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "With this designation, the FDA recognizes that our preliminary clinical data demonstrate that Pracinostat may result in a substantial improvement in the lives of AML patients over available therapy. We have worked closely with the FDA to get to this point and now focus on executing our Phase III study and bringing Pracinostat to market as quickly and efficiently as possible." According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. A Breakthrough Therapy Designation has all the benefits of the fast track program together with more intensive guidance on an efficient drug development program and an organizational commitment involving senior managers.
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Post by jckrdu on Aug 1, 2016 13:05:12 GMT
Patience paid off. They went over 3 months without a PR.
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Post by harleyquinn on Aug 1, 2016 14:06:35 GMT
Patience paid off. They went over 3 months without a PR. Define paid off. My cost basis here is 1.75. Wondering where you see this one going from here?
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Post by RLC on Aug 1, 2016 14:36:55 GMT
Patience paid off. They went over 3 months without a PR. Define paid off. My cost basis here is 1.75. Wondering where you see this one going from here? Jim any idea how many shares Vivo has left? With the kind of volume we saw this morning, I'm assuming they were actively selling quite a bit. Obviously would like to see us up higher right now, but up 10% on almost 20x daily average volume isn't too bad.
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Post by jckrdu on Aug 1, 2016 15:11:43 GMT
Define paid off. My cost basis here is 1.75. Wondering where you see this one going from here? Jim any idea how many shares Vivo has left? With the kind of volume we saw this morning, I'm assuming they were actively selling quite a bit. Obviously would like to see us up higher right now, but up 10% on almost 20x daily average volume isn't too bad. Not sure how many shares Vivo has left.
And not sure where this one is headed short-term, but at $1.50 its only a $50M market cap, which IMO is pretty low for a company moving into Phase 3 with Breakthrough Designation. So, while I have a large position here and was expecting a larger move on this news, I actually added on the pullback to $1.45 this morning. Still a small gap in the chart, but I just look at what happened with CPXX, and think MEIP should be able to land a partner with great terms given Breakthrough Designation. The combo trial was done with Celgene, so they're the likely partner.
There is risk of a capital raise if they do Phase 3 alone, but I just can't see them raising cash at this low market cap. I'm expecting more news and will consider taking some off the table at $2ish.
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Post by jckrdu on Aug 1, 2016 15:26:14 GMT
IMO, market wants to know how they intend to pay for the upcoming large (500 patient Phase 3 Prac trial), plus the 2 other new trials starting Q2 this year.
Hopefully, they'll announce positive median overall survival (MOS) for Prac to get the pps higher before raising any capital. That would seem to make the most sense, as raising capital before MOS is announced would make no sense, as they're sitting on $50M cash on the balance sheet and shouldn't be desperate to raise cash before announcing the very positive MOS news.
Partnership news for any of those 3 trials would be great.
They may be working to finalize the Phase 3 Prac trial design with the FDA (SPA would be great) before announcing a partnership. We should be hearing news soon on path forward.
Bumping this post back from April.
Bolding above still in play... market waiting to hear on how they're going to fund the trials before we see a major move, IMO...
On second bolded sentence, that's still my belief: they were working to finalize the Phase 3 trial design before announcing a partnership. With Phase 3 design finalized and Breakthrough in-hand, it seems like now's the time to partner. We'll see.
Could see a pullback if we don't get timely follow-on news.
Two additional trials were guided to start in Q2 2016 and are past due for news.
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