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Post by silentbob on Apr 7, 2014 15:28:36 GMT -5
I am not surprised by the delay Again I in no way want to come to the rescue of the FDA but what the panel suggested be done post approval is a lot to figure out and organize. Mannkind (and a future potential partner) will want to make certain everything gets done right post approval. If it's all just about the label and the panel recommendation, that should be a cause for the FDA to miss the PDUFA date, and NOT the cause of a PDUFA extension. A PDUFA extension is for analyzing additional data submitted by the sponsor close to PDUFA date. In this case, the FDA may have requested additional data so it could be used as an excuse to cover up their poor ADCOM planning, |
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Post by esstan2001 on Apr 7, 2014 15:33:53 GMT -5
dimwits...
a)who else would suggest titrating Insulin Aspart up in the non-TI arm of the T1 trial? or
b)suggest high insulin injection dosing in rats to see if there will be lung carcinogen signals?
I think the investigator's answers were a) if I did that, I would likely kill the patient and b) the rats would die of a hypoglycemic event
Reviewers in a diabetic drug trial that exhibit a total lack of understanding of how the drugs work... these are green kids.
There is no longer much continuity in terms of knowledgeable FDA staff for these long term drug reviews.
All the experienced career researchers and reviewers have since retired.
Why wouldn't they.
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Post by silentbob on Apr 7, 2014 15:34:05 GMT -5
If approved-- I feel a partner will be announced shortly after thereafter and we get another bounce. There are some here who believe that when approved it will be a partner and some believe it will just be a straight buyout. I am thinking partner because over the next few years, the stock should significantly increase and this has been Al Mann's MO but after so long and so much up and down-- a buy out would not be all that bad. I don't believe in a buyout at this stage. I find it very unlikely that any bidder could come up with a number that would satisfy Alfred Mann. The speculation around a buyout may be caused by an underestimation of the potential of Afrezza. I believe a partnership is the best bet. Let us hope Mannkind does not wait for approval. That factory needs machines, and those reps need recruiting and training. |
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Post by goyocafe on Apr 7, 2014 15:34:45 GMT -5
I am not surprised by the delay Again I in no way want to come to the rescue of the FDA but what the panel suggested be done post approval is a lot to figure out and organize. Mannkind (and a future potential partner) will want to make certain everything gets done right post approval. If it's all just about the label and the panel recommendation, that should be a cause for the FDA to miss the PDUFA date, and NOT the cause of a PDUFA extension. A PDUFA extension is for analyzing additional data submitted by the sponsor close to PDUFA date. In this case, the FDA may have requested additional data so it could be used as an excuse to cover up their poor ADCOM planning, According to the email that Stevie Ray shared with us from Matt, they have not been asked for any additional informaiton. All information was requested and submitted "months ago". |
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Post by silentbob on Apr 7, 2014 15:46:05 GMT -5
dimwits... a)who else would suggest titrating Insulin Aspart up in the non-TI arm of the T1 trial? or b)suggest high insulin injection dosing in rats to see if there will be lung carcinogen signals? Also c) Who else would try to cast a negative light on the fact that the Afrezza arm could use more Basal insulin (with less hypos) d) Who else would basically ignore major benefits like reduced hypos and reduced PPG in favor of a tiny A1c difference. There were some other nuggets in the documents as well. I'm just a little worried because there are so many of these 'dimwitted' statements by the FDA, that it starts looking like they are intentionally crafted to achieve a goal. |
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Post by silentbob on Apr 7, 2014 15:51:28 GMT -5
According to the email that Stevie Ray shared with us from Matt, they have not been asked for any additional informaiton. All information was requested and submitted "months ago". Yet they did not extend the PDUFA data months ago, when said data was submitted. Does that not further lend credence to the argument that this data was not the real reason? Also if additional data was requested before the ADCOM, that does not preclude the data submission from being used as an excuse later on, does it? |
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Post by goyocafe on Apr 7, 2014 15:52:07 GMT -5
Could they be trying to "starve" MNKD out of existence and therefore never have to render a decision?
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Post by goyocafe on Apr 7, 2014 16:02:06 GMT -5
"Also if additional data was requested before the ADCOM, that does not preclude the data submission from being used as an excuse later on, does it?"
As much as we'd like it, I don't think the FDA has to rationalize their actions, at least not to us. My guess is they can do whatever they want with whatever data they have, no matter when they got it. Perhaps they can explain it to an oversight committee, but that won't do us much good either. If it ever gets to that, MNKD will probably be BK.
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Post by esstan2001 on Apr 7, 2014 16:04:15 GMT -5
"I'm just a little worried because there are so many of these 'dimwitted' statements by the FDA, that it starts looking like they are intentionally crafted to achieve a goal."
I tend to wonder if the shorts had a mole in the FDA since their talking points mirrored what was published in the Briefing Docs so well...
I too also wonder if the FDA had an unfriendly agenda (political, BigPharma, or just adversarially motivated)
I think we will be OK as the reviewers are not generally the deciders... at this point they need to generate a supporting presentation that justifies the AdCom result, IMO they do not have any other choice.
The suggestion to write your congress person is as the Brit's tend to say, 'Brilliant'.
I will be following up on that.
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Post by silentbob on Apr 7, 2014 16:24:48 GMT -5
Could they be trying to "starve" MNKD out of existence and therefore never have to render a decision? That would be exceptionally cruel. It seems to me like such a thing would not be possible though. On one hand you have the potential for leaks ... AfrezzaGate anybody? On the other hand after too many delays the backlash from the public would be overwhelming and heads would roll. |
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Post by silentbob on Apr 7, 2014 16:30:30 GMT -5
I tend to wonder if the shorts had a mole in the FDA since their talking points mirrored what was published in the Briefing Docs so well... I too also wonder if the FDA had an unfriendly agenda (political, BigPharma, or just adversarially motivated) I think we will be OK as the reviewers are not generally the deciders... at this point they need to generate a supporting presentation that justifies the AdCom result, IMO they do not have any other choice. The suggestion to write your congress person is as the Brit's tend to say, 'Brilliant'. I will be following up on that. It doesn't even have to be an all-out mole. One reviewer that fancies a job with Novo Nordisk someday could mean loads of trouble for us. And how would you ever prove it? You're right, the greatest risk is behind us. But not all risk. It would be great if we could discourage them from looking for more excuses... |
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Post by alcc on Apr 7, 2014 17:21:17 GMT -5
dimwits... a)who else would suggest titrating Insulin Aspart up in the non-TI arm of the T1 trial? or b)suggest high insulin injection dosing in rats to see if there will be lung carcinogen signals? Also c) Who else would try to cast a negative light on the fact that the Afrezza arm could use more Basal insulin (with less hypos) d) Who else would basically ignore major benefits like reduced hypos and reduced PPG in favor of a tiny A1c difference. There were some other nuggets in the documents as well. I'm just a little worried because there are so many of these 'dimwitted' statements by the FDA, that it starts looking like they are intentionally crafted to achieve a goal. Spot on! However, nothing scares me more than someone who is ignorant -- and firm in his ignorance. |
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