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Post by jckrdu on Jan 21, 2016 21:27:52 GMT
Plan still to begin ph 3 registration in the 2nd half of 2016. Check the latest presentation with data from ash and further guidance if you aren't familiar with this company. Am I crazy to think partnership on AML is still in the works here? See Celgenes most recent 10q and look at the sales in Vidaza. Why wouldn't they have any interest in Pracinostat? Data is far superior to Vidaza at this point and still maturing. Could they be waiting to strike a deal until median os is reached? Data was just presented a month ago, don't deals take time? I feel like everyone is jumping ship right now based on current market conditions and fear of capital raise, neither of which seem logical to me. Anyway looks like events were updated on the website, they are presenting at the BIO CEO & investor conf Feb 8th. Maybe we hear something good investor.meipharma.com/events-webcastsAgree. Thanks for the update.
I'm still holding, as median overall response still hasn't been reached, and I believe they'll announce it when it is. That should be a decent catalyst. I may take some off the table after that news.
Beyond that, I'm also hoping they don't execute Phase 3 alone, but sign-up a partner. With great Phase 2 results, that would seem like the logical path forward... but who knows. They'll need to raise more cash if they execute Phase 3 alone, which is why the pps is where it is. Any indication from management that they intend to partner for execution of the Phase 3 trial, and it should start to move. If they indicate they're going Phase 3 alone, we'll probably see more downside.
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Post by Macgruber on Jan 22, 2016 20:56:20 GMT
yessir agree on all points. Im holding aswell and will continue to add if nothing material changes over the next week or two, although I need to be careful here. The risk is still significant. Thanks for the input
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Post by johank on Feb 16, 2016 17:37:51 GMT
Hmmm. SAC gets out and we have a slight bump up?
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Post by jckrdu on Mar 2, 2016 18:15:04 GMT
Been adding more here. Looking for median OS news on AML once median OS is reached. Should be at 17 months median OS right now.
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Post by jckrdu on Mar 3, 2016 18:16:49 GMT
Plan still to begin ph 3 registration in the 2nd half of 2016. Check the latest presentation with data from ash and further guidance if you aren't familiar with this company. Am I crazy to think partnership on AML is still in the works here? See Celgenes most recent 10q and look at the sales in Vidaza. Why wouldn't they have any interest in Pracinostat? Data is far superior to Vidaza at this point and still maturing. Could they be waiting to strike a deal until median os is reached? Data was just presented a month ago, don't deals take time? I feel like everyone is jumping ship right now based on current market conditions and fear of capital raise, neither of which seem logical to me. Anyway looks like events were updated on the website, they are presenting at the BIO CEO & investor conf Feb 8th. Maybe we hear something good investor.meipharma.com/events-webcastsAgree. Thanks for the update.
I'm still holding, as median overall response still hasn't been reached, and I believe they'll announce it when it is. That should be a decent catalyst. I may take some off the table after that news.
Beyond that, I'm also hoping they don't execute Phase 3 alone, but sign-up a partner. With great Phase 2 results, that would seem like the logical path forward... but who knows. They'll need to raise more cash if they execute Phase 3 alone, which is why the pps is where it is. Any indication from management that they intend to partner for execution of the Phase 3 trial, and it should start to move. If they indicate they're going Phase 3 alone, we'll probably see more downside.
Low volume, but some signs of life here the past few days.
Waiting for news...
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Post by Macgruber on Apr 2, 2016 13:12:14 GMT
Agree. Thanks for the update.
I'm still holding, as median overall response still hasn't been reached, and I believe they'll announce it when it is. That should be a decent catalyst. I may take some off the table after that news.
Beyond that, I'm also hoping they don't execute Phase 3 alone, but sign-up a partner. With great Phase 2 results, that would seem like the logical path forward... but who knows. They'll need to raise more cash if they execute Phase 3 alone, which is why the pps is where it is. Any indication from management that they intend to partner for execution of the Phase 3 trial, and it should start to move. If they indicate they're going Phase 3 alone, we'll probably see more downside.
Low volume, but some signs of life here the past few days.
Waiting for news...
Hey jckrdu I'm still here, just been waiting and waiting with my fingers crossed. I found a knowledgible perspective on Pracinostat the other day. Not familiar with this poster but he hits the nail on the head for me with regards to CPX-351 vs Pracinostat, (see below). I've been a big believer in a possible CELG buyout forever now. Probably far fetched but a guy can dream can't he? From ltbiovestor "I own both stocks. Bought CPXX 2 years ago and holding onto all my shares after last week's data- believe it is worth much more. Bought MEIP 9 months ago, agree it is dirt cheap (business essentially valued at near 0, excl cash), and also expect it to go higher eventually when people come back to it- quite forgotten now. A few points: I do think you are confounding patient populations as there is limited overlap between both companies' target AML patients. As such, there is room for both CPX-351 and Pracinostat in AML treatment, as both extend patients' lives materially. 1. CPX-351's patients are FIT, ie, able to tolerate (previously) standard 7+3 chemo. In the Ph3, CPX-351 patients population was elderly sAML which is a high risk patient group. CPX-351 will likely replace 7+3 for all fit patients and will likely become the new standard of care for people who previously would have been given 7+3. 2. Pracinostat so far has been used (in Ph2) in elderly UNFIT patients, ie, those unable to tolerate induction chemo (7+3). Also, the patient group was all risk categories, ie, low, intermediate, and high risk patients. This is why comparing Pracinostat's OS (probably 18 months by now, not the 16.5 you cited) to CPX-351's 10 months is not appropriate. What does matter is that Pracinostat's is 18+ months vs. best to date of 10 months with azacitidine (Vidaza). Of course, htis next needs to be confirmed in a larger Ph3 trial with a control arm, but the Ph2 data is pretty convincing. I don't think it is a fluke. 3. I think MEIP's management waiting to do the Ph3 was a good, prudent decision. The company is blessed with ample cash, but blowing a Ph3 trial is not a mistake they can afforrd. Starting the Ph3 now that they have an extremely high probability of success, given the ph2 data, makes sense. It also enables them to potnetially partner the asset, if there is interest. CELG, the maker of Vidaza, is a logical candidate, since the Ph2 uses Pracinostat in combination with Less"
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Post by jckrdu on Apr 2, 2016 15:43:05 GMT
Low volume, but some signs of life here the past few days.
Waiting for news...
Hey jckrdu I'm still here, just been waiting and waiting with my fingers crossed. I found a knowledgible perspective on Pracinostat the other day. Not familiar with this poster but he hits the nail on the head for me with regards to CPX-351 vs Pracinostat, (see below). I've been a big believer in a possible CELG buyout forever now. Probably far fetched but a guy can dream can't he? From ltbiovestor "I own both stocks. Bought CPXX 2 years ago and holding onto all my shares after last week's data- believe it is worth much more. Bought MEIP 9 months ago, agree it is dirt cheap (business essentially valued at near 0, excl cash), and also expect it to go higher eventually when people come back to it- quite forgotten now. A few points: I do think you are confounding patient populations as there is limited overlap between both companies' target AML patients. As such, there is room for both CPX-351 and Pracinostat in AML treatment, as both extend patients' lives materially. 1. CPX-351's patients are FIT, ie, able to tolerate (previously) standard 7+3 chemo. In the Ph3, CPX-351 patients population was elderly sAML which is a high risk patient group. CPX-351 will likely replace 7+3 for all fit patients and will likely become the new standard of care for people who previously would have been given 7+3. 2. Pracinostat so far has been used (in Ph2) in elderly UNFIT patients, ie, those unable to tolerate induction chemo (7+3). Also, the patient group was all risk categories, ie, low, intermediate, and high risk patients. This is why comparing Pracinostat's OS (probably 18 months by now, not the 16.5 you cited) to CPX-351's 10 months is not appropriate. What does matter is that Pracinostat's is 18+ months vs. best to date of 10 months with azacitidine (Vidaza). Of course, htis next needs to be confirmed in a larger Ph3 trial with a control arm, but the Ph2 data is pretty convincing. I don't think it is a fluke. 3. I think MEIP's management waiting to do the Ph3 was a good, prudent decision. The company is blessed with ample cash, but blowing a Ph3 trial is not a mistake they can afforrd. Starting the Ph3 now that they have an extremely high probability of success, given the ph2 data, makes sense. It also enables them to potnetially partner the asset, if there is interest. CELG, the maker of Vidaza, is a logical candidate, since the Ph2 uses Pracinostat in combination with Less" Thanks for the information, good post.
Some sort of deal with CELG seems like the most likely path forward, which is why I continue to hold/add as well. Yeah, a buyout would be great. Not counting on that but anything's possible given the great combo results were achieved with CELG's current treatment.
I've been adding in the $1.20s, as I believe this will get back to $2ish over the next few months on 1) the two Phase 2 trial initiations that have been guided to start in Q2 (should get more eyes back on the stock) and 2) the Pracinostat/combo MOS news release... which the CEO said they'll PR when MOS is reached... should be at least 18 months now.
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Post by jckrdu on Apr 11, 2016 17:40:26 GMT
Looking for some good news at tomorrow's presentation/conference to let this move up continue.
GL all.
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dave
Junior Member
Posts: 87
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Post by dave on Apr 11, 2016 21:33:57 GMT
it's an interesting story they have. a suppressed share price largely b/c the patients in their study are living long past expectation, so that they can't yet report data...lol.
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Post by Macgruber on Apr 12, 2016 12:11:22 GMT
it's an interesting story they have. a suppressed share price largely b/c the patients in their study are living long past expectation, so that they can't yet report data...lol. Haha it is funny when you look at it that way. I've felt for the longest time now that no news is good news in the AML data as it continues to "mature", but I guess not bc fear of a self funded ph 3 and market conditions just drug the price down. Totally opposite of what I figured would happen, what a friggin conundrum
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Post by jckrdu on Apr 12, 2016 19:39:18 GMT
Slides are up on Webcast starting at 3:40 PM EST today.
On slide 20, data will be released on 4/20 for ME-401; Phase 1 data. Could keep folks invested.
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Post by Macgruber on Apr 12, 2016 21:10:01 GMT
Slides are up on Webcast starting at 3:40 PM EST today. On slide 20, data will be released on 4/20 for ME-401; Phase 1 data. Could keep folks invested. Is the presentation still going? having a hard time connecting, Im assuming its over and ill have to wait till tomorrow. Looking through slides now. So AML data clearly beats CPXX out on a tougher population no?
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Post by jckrdu on Apr 12, 2016 21:15:39 GMT
Slides are up on Webcast starting at 3:40 PM EST today. On slide 20, data will be released on 4/20 for ME-401; Phase 1 data. Could keep folks invested. Is the presentation still going? having a hard time connecting, Im assuming its over and ill have to wait till tomorrow. Looking through slides now. So AML data clearly beats CPXX out on a tougher population no? Presentation is over. You should be able to listen to recording...
Prac Phase 3 trial planned - 500 patients. No word on costs, or potential partnership. Still plan to initiate 2nd half 2016. Prac Median overall survival still not reached. At 18+ months now. (So that PR is still coming sometime soon.) Some nice market research slides on Prac and projected uptake by docs. ME-401 Phase 1 data to be released 4/20 at conference.
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Post by Macgruber on Apr 12, 2016 21:40:37 GMT
Is the presentation still going? having a hard time connecting, Im assuming its over and ill have to wait till tomorrow. Looking through slides now. So AML data clearly beats CPXX out on a tougher population no? Presentation is over. You should be able to listen to recording...
Prac Phase 3 trial planned - 500 patients. No word on costs, or potential partnership. Still plan to initiate 2nd half 2016. Prac Median overall survival still not reached. At 18+ months now. (So that PR is still coming sometime soon.) Some nice market research slides on Prac and projected uptake by docs. ME-401 Phase 1 data to be released 4/20 at conference. thx listening now
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Post by Macgruber on Apr 12, 2016 22:02:43 GMT
Is the presentation still going? having a hard time connecting, Im assuming its over and ill have to wait till tomorrow. Looking through slides now. So AML data clearly beats CPXX out on a tougher population no? Presentation is over. You should be able to listen to recording...
Prac Phase 3 trial planned - 500 patients. No word on costs, or potential partnership. Still plan to initiate 2nd half 2016. Prac Median overall survival still not reached. At 18+ months now. (So that PR is still coming sometime soon.) Some nice market research slides on Prac and projected uptake by docs. ME-401 Phase 1 data to be released 4/20 at conference.
Haven't gotten to the projected uptake by docs, but I see one patient died since ASH . Still two away from median os. I really liked the slide with the Kaplan meier on the association of survival with cr. Of the people who achieved a CR 85% still alive past two years and counting
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Post by jckrdu on Apr 14, 2016 13:49:35 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.
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Post by jckrdu on Apr 14, 2016 19:15:48 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. Nice move on heavy volume.
Hopefully, some of the institutions that sold a year ago in early 2015 after the Phase 2 results (when MEIP was trading in the $4 - $6 range), are now just starting to re-accumulate based on further analysis of the Phase 2 data and the move into Phase 3. Too early to say if that's what's happening, but I like the recent volume.
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Post by JHam on Apr 15, 2016 13:58:48 GMT
Up another 9% right out of the gate today. Well done for those of you who bought this one over the past few weeks/months.
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Post by RLC on Apr 15, 2016 14:26:21 GMT
Up another 9% right out of the gate today. Well done for those of you who bought this one over the past few weeks/months. Thanks to Jckrdu and MacGruber, I opened a position a month or so ago at $1.15. Just doubled down on that position this morning at $1.75 (now averaged at $1.45). I can't see this not jumping huge once they reach median OS and it's announced. Thought the table below was very revealing:
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Post by selluwud on Apr 15, 2016 14:40:38 GMT
Up another 9% right out of the gate today. Well done for those of you who bought this one over the past few weeks/months. Thanks to Jckrdu and MacGruber, I opened a position a month or so ago at $1.15. Just doubled down on that position this morning at $1.75 (now averaged at $1.45). I can't see this not jumping huge once they reach median OS and it's announced. Thought the table below was very revealing: I have a similar average and will part with some very soon, maybe half before the actual reveal to protect some profit.
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