Wednesday, December 1, 2010
Oppenheimer update – Nov 30-2010
Previewing AFREZZA 12/29 PDUFA; Anticipate FDA Rejection, New Studies
We are previewing FDA's decision on MNKD's AFREZZA, which is expected to occur by the 12/29 PDUFA date. Importantly, (1) we continue to anticipate a complete response letter (CRL) for AFREZZA, with FDA requesting additional data from MNKD. (2) We view the lack of an FDA advisory panel prior to the PDUFA as an additional negative for the prospects of AFREZZA approval. (3) We note that diabetes products in general have a history of regulatory delays and expect a similar outcome with AFREZZA. (4) We believe that although not explicitly stated by MNKD, FDA may have suggested additional studies be run in the CRL received 3/16/10, making it difficult to interpret MNKD's statements regarding contents of any future CRL received.
Anticipate CR for AFREZZA, Expect Additional Trials Needed. We continue
to believe that AFREZZA data is not adequate for approval, specifically due to
the failed TI-117 trial in Type 1 diabetics. Importantly, we see substantial
downside for MNKD's shares upon the FDA decision expected Dec 29.
View Lack of FDA Panel as Additional Negative for AFREZZA. In our view,
the FDA is not likely to approve an inhaled insulin product without an advisory
panel. The safety barrier for diabetes drugs is extremely high, and AFREZZA
does not improve HbA1c reduction vs. injected insulin.
Diabetes Products Have Unfavorable Regulatory History. FDA approval for
diabetes drugs has become increasingly difficult, suggesting a negative
outcome for AFREZZA. Importantly, many diabetes drugs have been rejected
and permanently discontinued. Finally, approved drugs have been delayed 22
months on average.
"No New Data" Claim Meaningless Going Forward. MNKD noted FDA "did
not request new clinical data" in the March 2010 complete response (CR), but
has likely submitted data from TI-117. Also, MNKD disclosed that FDA cited
Why did they approve Exubera if there is a lung effect i.e. coughing issue here? Was not the effect on the lungs similar? What was it about Exubera that did not cause a coughing problem/safety problem??? I'm confused now - is this a scam leading to a CRL???
Why did they approve Exubera? It must be the same as it relates to effect on the lungs??? What are your thoughts??
The rule basically states that a company's Phase III trial will be a failure if the trial is cancer related and the company has a market capitalization of under $300 million with 120 days or less to go before the data release. His rule was right for the first drug for KERX - the results were good for their second drug and hence Rule was wrong - and now it is at 14 from 1.75- he got the first drug right but the second wrong - since then have not hear much of his Rule. more like 50%
Was he the one that said that no drug under a billion cap can get approved some rule and coined - and he said KERX results would not be positive - someone please refresh my memory? I only remember 2 he got right DNDN and some other one...
If Exubera got approved why should not Afrezza? Are they mechanisms different? Why is there so much worry? Was no the last rejection somewhat trivial in nature - i.e. an easy fix? Please help with answers - thank you!
what is this worth if P3 go well and what is the price if FDA approval for PC? Anyone have a guess? Thanks.
Who is Orr???? is it credible?
Thanks all!!! I panic too easily - probably should not buy stocks in the first place but was impressed by the P2 results on metastasized prostrate cancer cells.
Why does it say $24????? What was the reason for the downgrade?? What if the P3 go well - is this down grade based on an assumption that P3 data will be poor??? Please explain.
the point being that there is talk that MDVN would be the preferred drug for PC? Is EXEL to be used at a different stage than MDVN? Thanks if you know the answer.
Why do you believe MDVN is better than EXEL? are the mechanisms the same? Doesn't EXEL shrink tumors that have metastized more so than MDVN?