The projected completion date (336 days for a patient to reach the final clinical evaluation) conforms to the projected September 2016 date in the FDA filing. However, I think that with the final patients being enrolled, they are going to start work towards "unblinding" the clinical data and as soon as they reach a 50 treated patient - 50 control patient evaluation point and get any clinically significant treatment benefits, I think they might file. I also suspect that if they got a clear distinction between treated and control, they may apply for EAP (Expanded Access Protocol) and get some of the control patients treated and/or add more patients to the study. The EAP approach has been used by Insmed a couple of times for their CF and NTM applications.

Investors in new biopharma companies . . .

should understand that the regulatory process takes years (clinical trials, reporting clinical trials, review of clinical trials by regulatory agencies, filing the final documents for commercialization, etc.). The future prospects for these stocks are based on the medical endpoints and benefits that can be achieved (in the case of Aradigm, the numbers of bacteria in the lungs that can be killed during a 28 day course of inhaling antibiotics). For a stock analyst group like Capitol Cube to comment on the risk of success of Aradigm (a company not selling any product) in comparisons to companies that are selling products . . . without mentioning the scientific basis and achievements of Aradigm has got to be the stupidest investment analyst statement ever. Overlooking the fact that the Cipro liposome kills up to 4 logs of bacteria in the lungs just shows that the commentators should be offering comments on the competitiveness of one company versus another in selling shoe laces, or mouthwash. Inhalational Cipro will eventually be used with systemically administered Cipro which will kill any bacteria in the lungs twice as fast. And will be safer then other inhalational antibiotics that cannot have their non-liposome counterpart administered systemically at the same time. More than 40 years ago, I would treat dogs with ear infections with antibiotics instilled in the infected ears at the same time I gave the dogs oral antibiotics that would be secreted in the exudate coming out of the tissues. I cleared up most infections in 10 days and seldom had reinfections. It is just all sound medical practice.

Full enrollment has been achieved for both Phase III trial. Now the follow up treatments and monitoring has to be completed (I reviewed the protocol which suggested 6 X 56 or 336 days to final stats. But the patients that have completed the trial over the last year can now have their records unblended, collated and statistically analyzed. If the lipid Cipro achieves results like in the Phase IIb trial (3-4 logs of kill) it will be given expedited review and will probably be licensed within a year.

Also, remember, there are probably milestone that have been met in the Grifols deal which will be bringing in more payments against the $80 marketing deal. We shall see pretty soon . . . my guess is late Spring.

In the meantime the "analists" will be spouting more blather. As if they knew their elbow from their profession!?!

The last patient was enrolled in the Phase III ARDM study in December. It is a waiting game because the cycle of treatments is 340 days. So there are about 250 days left before that patient gets through the protocol. But that does not mean that the patients who are through Rx cannot have their data collated and start to be analyzed. Remember it is the "logs of bacteria killed" that was outstanding in the Phase IIb. Each "log" is equal to 10. So four logs is 10,000 bacteria per ounce of sputum. That is more than TOBI, tobramycin powder, Arikayce, etc. As soon as ARDM gets to the milestone for bronchiectasis, I think they are going to go after NTM.

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