An interesting exposé in bashing that would take too much of my time to answer in total. This is a distortion of the facts and demonstrates lack of any DD. (Investing in the highly risky biotech sector requires an extraordinary amount of DD – a biology/physiology/biochemistry background is a plus.) Exwannabe has not followed the recent events for IDMI’s Junovan (L-MTP-PE) in professional publications regarding, the recent reversal by the ODAC, the recent allowance by the FDA for Compassionate Access of Junovan. A few quick comments:
“Juno only showed a benifit (sic) when another UNAPROVED (sic) drug was used” I have been following this company from the beginning – this is news to me. Just what are you talking about.?
“The database was seriously flawed” You are correct. I was a statistician in the early years of my scientific career. Frequently trials do not go as planned and require revised statistical procedures and often more data gathering. IDMI had to do the latter. The trial for Junovan (M-MTP-PE) had issues that only could be resolved by a follow up (more data gathering) of the patients who received the treatment. The initial FDA rejection was based on incomplete data. The follow up of the trial patients provided enough data to show that there is a statistical benefit for the use of Junovan. The recent positive news indicates to me that we should have smooth sailing with Junovan to FDA approval.
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