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Post by alcc on Jan 10, 2014 21:39:44 GMT -5
What do you mean by nice try?
I was not implying equivalence between the Merck compound and Afrezza. The take away should be that the adcom in that case essentially pushed a dosing hypothesis that the company had rejected. The adcom did not reject the compound. They voted favorably on safety and efficacy. But they wanted more tests done using a dosing model that the company had rejected ex ante on safety grounds.
I am not surprised FDA sought an adcom re Afrezza and I have not changed my bullish views. What I am trying to point out is that this injects another layer of risk -- of delay at the very least.
If you think PFE is the likely partner, good luck with that, oracle.
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Post by liane on Jan 10, 2014 21:47:04 GMT -5
The FDA poses a set of questions to the committee, including ones re safety, sufficiency of data, scope of label etc. After hearing presentations from the company experts and asking a bunch of questions the committee takes a vote on each question. Simple majority governs. Does not appear to be merely advisory. In other words, it appears the FDA will simply adopt adcom's decisions. The problem is, imo, whenever you have a diverse group of people they will bring their ideological biases to the table. Plus, it's not skin off their nose to ask for more tests and more data. Overall, this is not good news. I'd say greater than 50% chance they will ask for more tests, which means in-complete response and re-submission. Otoh, hard for me to believe a majority of experts will flat out vote to reject. alcc, The Adcom vote is non-binding on the FDA, although they often follow the recommendation. I remain very neutral on this development until we see the content of the briefing documents. Afrezza has been shown to be safe, effective, non-inferior. It is convenient and improves compliance. What tests do you think would be asked for that would delay approval (many tests can be done post-approval)? |
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Post by alcc on Jan 10, 2014 22:01:24 GMT -5
Liane, Yes, I know it is technically non-binding. But if you look at the McKinsey study, the FDA follows the adcoms in 80+% of the cases, both re approvals and rejections. Did you see the (approval) delays due to adcoms in that report? That blew me away.
I have no idea what additional tests the adcom might ask for. That's my point. It could be completely arbitrary. Don't you think the Merck case was kind of arbitrary?
Anyways, I hope it's a slam dunk.
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Post by babaoriley on Jan 10, 2014 22:29:39 GMT -5
alcc, you wrote: "Overall, this is not good news. I'd say greater than 50% chance they will ask for more tests, which means in-complete response and re-submission." And in response to oracle you write, "I am not surprised FDA sought an adcom re Afrezza and I have not changed my bullish views."
Something's wrong here, wouldn't you say? Are you bullish that after the tanking we're more likely than not to endure based on your statement above regarding greater than 50% chance the FDA will ask for more tests, the company will finally dilute some more at about $1.25 per share, go through another year and a half of "tests," go through another submission to the FDA, and potentially get another PDUFA date in 2017 or so, that's when your "bullish views" will come be realized?
It's okay to be short, alcc, I've suspected you are before, but the above pretty much seals it. I've got no problem with overtly short, it's sneaky short that is upsetting - and I'm not sure I'll be able to get over this tonight!
Good luck, just not with MNKD!
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Post by alcc on Jan 10, 2014 23:12:42 GMT -5
Baba, first of all, I will ignore your ad hominem. We all had a bad day. So I'll give you a pass. Let me assure the rest of you not only am I a bull with a large long position, I detest shortsellers as a rule. Read my prior posts. But all that's irrelevant. What I tried to inject into the discussions here is a sense of reality re valuation, partnership structure etc. I, too, would love to see a $70 take out next week. But I don't think that's going to happen. That's the difference between me and many of you. Otoh, whereas I have stated in past posts that I am prepared to hold past approval, many of you were talking about lightening up on expectation of a partnership deal pre approval. Who's the real bull here?
You are correct that I see adcom as not good news. Do you think that's good news? I was wrong to put a figure (>50%) to my speculation. I have no idea. But I am upset. My concern that the adcom might ask for more tests arises from the McKinsey report showing the time lapse between adcom meeting and final fda approval. For those cases where >66% of the adcom voted for approval, the avg time to approval was 140 days. For those cases where 33-66% voted for approval the avg time to approval was 190 days. For those cases where the adcom vote was less than 33%, the avg time to approval was a whopping 699 days! Why the delay, if not for additional test data? Read the report for yourselves. Too bad the report does not indicate percent of cases where additional tests were requested; thus, I had to infer.
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Post by Chris on Jan 11, 2014 0:15:22 GMT -5
Baba, first of all, I will ignore your ad hominem. We all had a bad day. So I'll give you a pass. Let me assure the rest of you not only am I a bull with a large long position, I detest shortsellers as a rule. Read my prior posts. But all that's irrelevant. What I tried to inject into the discussions here is a sense of reality re valuation, partnership structure etc. I, too, would love to see a $70 take out next week. But I don't think that's going to happen. That's the difference between me and many of you. Otoh, whereas I have stated in past posts that I am prepared to hold past approval, many of you were talking about lightening up on expectation of a partnership deal pre approval. Who's the real bull here? You are correct that I see adcom as not good news. Do you think that's good news? I was wrong to put a figure (>50%) to my speculation. I have no idea. But I am upset. My concern that the adcom might ask for more tests arises from the McKinsey report showing the time lapse between adcom meeting and final fda approval. For those cases where >66% of the adcom voted for approval, the avg time to approval was 140 days. For those cases where 33-66% voted for approval the avg time to approval was 190 days. For those cases where the adcom vote was less than 33%, the avg time to approval was a whopping 699 days! Why the delay, if not for additional test data? Read the report for yourselves. Too bad the report does not indicate percent of cases where additional tests were requested; thus, I had to infer. I don't believe any of us believe MNKD will reach $70 by next week. I don't even know if there are any of us who believe MNKD will break $15 come FDA Approval time. I will say this, treat each drug adcom separately and on a individual case basis. Dipping from a non-correlated and unstated sample size is foolish when one wants to justify any point, as you have... I will say this: Deerfield reviewed the data and released the 2nd tranche based on the data reviewed and submitted FDA has requested Afrezza test on children <4 This adcom may just be requested with the expansion of MNKD's label and to verify if MNKD met in vivo safety efficacy and bioequivalence check this out: mannkind.freeforums.net/thread/295/mannkind-announces-tentative-advisory-committee(please delete or edit the link if this is not allowed, I figured it was useful for this case...) |
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Post by notamnkdmillionaire on Jan 11, 2014 0:17:13 GMT -5
I urge anyone interested in how an adcom operates (I assume everyone here) to read the following very interesting article. www.newyorker.com/reporting/2013/12/09/131209fa_fact_parker?currentPage=allThe FDA poses a set of questions to the committee, including ones re safety, sufficiency of data, scope of label etc. After hearing presentations from the company experts and asking a bunch of questions the committee takes a vote on each question. Simple majority governs. Does not appear to be merely advisory. In other words, it appears the FDA will simply adopt adcom's decisions. The problem is, imo, whenever you have a diverse group of people they will bring their ideological biases to the table. Plus, it's not skin off their nose to ask for more tests and more data. Overall, this is not good news. I'd say greater than 50% chance they will ask for more tests, which means in-complete response and re-submission. Otoh, hard for me to believe a majority of experts will flat out vote to reject. You might be right but ZGNX had an adcom that almost unanimously voted against their pure hydrocodone Zohydro and yet the FDA approved it. Care to explain that one with a drug that has caused a huge problems for many in this country due to addiction? |
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Post by alcc on Jan 11, 2014 0:52:54 GMT -5
Mnkdmillionaire,
You just made my point. Adcoms and FDA are both unpredictable. Add the two together...
Chris,
When I defended Morningstar's valuation of $6B (~$20/sh) as in the ballpark, I got attacked for being way too pessimistic. In what way have I used "non-correlated, unstated sample size to justify a point"? I am a mathematician. Of course every case is different. If you wish to challenge my inferences, at least read the source from which I quoted. I may be completely off base re my concerns re the adcom. I hope I am. But the knee-jerk, ill-informed, ad hominem I am getting is disappointing to say the least. I expected better when I joined this board. I won't be posting any more. Good luck to all.
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Post by babaoriley on Jan 11, 2014 2:32:57 GMT -5
You're a mathematician and you threw out less than 50% chance of approval and say your still bullish. I had a bad day too, but I can still think. And it is very apparent from you past posts that you are a sharp fellow. Good luck to you, too.
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Post by liane on Jan 11, 2014 7:16:22 GMT -5
My opinion, FWIW, is that the FDA had plenty of time to schedule an Adcom at a sooner date. So I'm in the camp that they are not worried about the short time frame and this will boil down to the label. I've only been through this with one other stock I owned, ARNA's lorcaserin (Belviq). The Adcom will have a very focused list of questions to discuss, and it will all boil down to yes/no vote. I don't think it is up to the Adcom to propose new tests. Here's the summary of lorcaserin questions to give you a flavor, and a link to their briefing doc: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303198.pdfDiscussion Points for Advisory Committee 1. Discuss whether the sponsor has provided an adequate response regarding diagnostic uncertainty for mammary tumors – i.e., adenocarcinomas versus fibroadenomas - in rats treated with lorcaserin. 2. Discuss whether the sponsor has provided an adequate response regarding the potential clinical risk associated with lorcaserin-induced mammary adenocarcinoma in rats (e.g., a sufficient safety margin). 3. Discuss whether the sponsor has provided sufficient evidence to conclude that elevation in plasma prolactin is the primary mode of action for the mammary tumors observed in rats. 4. Discuss whether the sponsor has provided an adequate response regarding the potential clinical risk associated with lorcaserin-induced astrocytoma in rats (e.g., a sufficient safety margin). 5. Taking into account the new in-vitro 5HT2 receptor potency data, discuss whether the phase 3 echocardiography data are sufficient to rule out a clinically meaningful increase in the risk for valvular heart disease in patients treated with lorcaserin. 6. Taking into account the March 28 and 29, 2012 advisory committee meeting on cardiovascular risk assessment of obesity drugs, discuss the available data to assess for excess risk for major adverse cardiovascular events in patients treated with lorcaserin. 7. Do the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals? If ‘Yes’, please provide your rationale and comment on the need for and approach to patient monitoring and risk management. Discussion Points for Advisory Committee If ‘No’, please provide your rationale and comment on what additional preclinical or clinical information should be required to potentially support approval. |
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Post by notamnkdmillionaire on Jan 11, 2014 8:28:52 GMT -5
Cowen and Piper have interpreted the late Adcom date to mean there will be a delay in approval. That might have what caused the serious sell off yesterday. Regardless, something is really fishy with how the last two day's trading went down.
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Post by liane on Jan 11, 2014 9:43:48 GMT -5
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Post by oracle on Jan 11, 2014 10:34:01 GMT -5
I too don't see a delay in PDUFA date since a AdCom wasn't required by the FDA in the 74 day letter. Is it possible that MNKD's suitor requested the AdCom to answer this question.
Can we use the Dreamboat Inhaler and Technosphere Technology with Exubera for Basel use in type 1 diabetics?
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Post by indigodaisy on Jan 11, 2014 10:42:02 GMT -5
I strongly feel the purpose of the Adcom is to discuss the label and that approval will go as scheduled. I am long and have been in this for many years and have weathered all the ups and downs and have learned to just be patient. I believe in the science and I believe in Al Mann's vision. What an inspiration this man is to me, to be as old as he is with so much passion and purpose. They will come through for us, I am sure of it. I see this as a buying opportunity. I am all in =) hang in there, we will all be celebrating soon enough!
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Post by liane on Jan 11, 2014 10:52:01 GMT -5
I too don't see a delay in PDUFA date since a AdCom wasn't required by the FDA in the 74 day letter. Is it possible that MNKD's suitor requested the AdCom to answer this question. Can we use the Dreamboat Inhaler and Technosphere Technology with Exubera for Basel use in type 1 diabetics? oracle, As best I can tell, Adcom is called solely at the discretion of the FDA. So neither MNKD nor a suitor would be able to request one. I suppose a hexameric insulin could be attached to Technosphere, but of course, clinical studies would have to be done. This would be a logical extension to be studied. |
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