Mannkind can either wait to have results from both Phase III trials Type I & Type II in hand before issuing one press release in the July/August time period or they can decide to announce Phase III results from the Type I study a month ahead of Type II . Phase III for Type I is an open label study and those results will become available well before the Phase III trial results for Type II,. Final data collection from the Type I study is already underway and preliminary top line results could be available for public disclosure as early as next month in June. Mannkind can and I believe should stagger the Phase III announcements especially if the Type I results come in very positive, which would be a shareholder friendly decision.
Based on all previous studies there is very little room for failure of Afrezza. In fact, at one point it was going to be approved. Just ask the Chinese dude in prison for trading on the inside information he had access to while working at the FDA.
Do a little more research and place your bets accordingly.
"Mannkind can and I believe should stagger" ?
Your brown eyes are showing again.
First, there is absolutely no "Strategy" for releasing results. Results are binary (pass/fail).
Second, Adding yourself to what your presume Mannkind believes does NOT give your statement any more credibility. It actually provides less credibility. Stop with the speculation BS as though you have some sort of inside track. You start to sound like a pumper!
If they learn that a trial result has failed to meet the primary efficacy endpoint, I suspect they will release that info immediately. Otherwise ... probably mid August, like they said, for both results.
The unblinded trial data has been monitored by an independent Data Monitoring Committee who could have shut the trials down at any time.
The following is from the U.S. Gov. Clinical Trials website and for the Type I Study, primary results are being analyzed starting in May 2013, with the entire trial completing in June which includes secondary results analysis. Given primary results are already being reviewed, I don't see why those results cannot come out by next month June. Mannkind could issue a press release in June captioned Positive Preliminary Top Line Primary Results Achieved. I just hope if the company doesn't decide to wait for all the data from both Phase III trials to available before they issue an announcement. If top line primary results are seen for the Type I primary outcome, they should immediately issue a press release. I see no reason to hold back Type I results if they are positive and known before Type II.
Primary Outcome Measures:
Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
FEV1 changes from Baseline to the final treatment visit compared between TI-Gen2C and TI-MedTone C treatment groups [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Comparison of mean change from randomization visit to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Comparison of mean 7-point glucose from the week before the randomization visit to those measured the week before the Week 24 visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change in body weight from Randomization to the end of the treatment period [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 471
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
I thought I already covered this in my comments late last evening......it is doubtful anything will be announced until both trials have been concluded! That is currently managements position......a poor one in my judgement, but nevertheless.....