Was there a credible reply/refute to Martin Shkreli ?

[harshal1981]

I recently came across a full document that Marin Shkreli send to FDA officials visa email right before the second CRL. I was wondering if there was any credible reply / refute was issued by any one (MNKD or any share holder who is considered industry expert or with credible knowledge of the science) ? 

Being a consultant in inhaler device technology, I did agree with FDA for the fact that the Gen2 device was way too different for establishing BE without in-vivo studies. However, I was really surprised at the claim from Shkreli that all the trials that MNKD ever conducted and presented, were all couldn't be accepted as appropriate. He in fact offered refutes to each individual trials. Which I can't comment since I haven't seen published results of old trials. 

Did FDA ever issued concern related to clinical utility of Afrezza as he claims? Or did MNKD management ever accepted that CRL raised concerns about the clinical utility established through the (old) trials was not acceptable? 

Seems, we have enough veterans on this board. Please point me to right direction. I want to do some digging this weekend. 

[babaoriley]

Many can give you more detail, here's what I remember: the CRL (2nd one, I believe) did have some language regarding questioning of the clinical utility of Afrezza. It seemed like a strange comment to me at the time, but I'm not qualified to say the comment was ridiculous. But, the FDA then met with MNKD and they helped prescribe a path that would lead to approval, which, to me, must mean that it would also lead to satisfying any issue or question regarding clinical utility. In my layman's mind, the clinical utility of Afrezza and an inhaler seems obvious, so there must be more to that phrase, but, again, these last trials were surely designed to clear that issue up.

[brentie]

Mar 15, 2014 15:14:00 GMT -5 harshal1981 said:

I recently came across a full document that Marin Shkreli send to FDA officials visa email right before the second CRL. I was wondering if there was any credible reply / refute was issued by any one (MNKD or any share holder who is considered industry expert or with credible knowledge of the science) ? 

Being a consultant in inhaler device technology, I did agree with FDA for the fact that the Gen2 device was way too different for establishing BE without in-vivo studies. However, I was really surprised at the claim from Shkreli that all the trials that MNKD ever conducted and presented, were all couldn't be accepted as appropriate. He in fact offered refutes to each individual trials. Which I can't comment since I haven't seen published results of old trials. 

Did FDA ever issued concern related to clinical utility of Afrezza as he claims? Or did MNKD management ever accepted that CRL raised concerns about the clinical utility established through the (old) trials was not acceptable? 

Seems, we have enough veterans on this board. Please point me to right direction. I want to do some digging this weekend. 

Harshal, The FDA did bring up clinical utility in the first CRL...

"The Complete Response letter related to the AFREZZA application requested several items, including information and currently available clinical data that support the clinical utility of AFREZZA and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials. The letter cited no safety concerns, but requested updated safety data related to AFREZZA. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons. "

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1402294&highlight

You can also see more on the CRL by reading Peter Richardson's dialogue here...

seekingalpha.com/article/202049-mannkind-corporation-q1-2010-earnings-call-transcript?find=letter%20utility&all=false



I don't recall them bringing up clinical utility in the second letter. Here's some info on the second CRL...

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1517413&highlight=

seekingalpha.com/article/252260-mannkind-ceo-discusses-q4-2010-results-earnings-call-transcript?find=letter%20utility&all=false


I hope this helps.