I provided this to Davidal over on the Cortex board and thought this should really be here (with some modifications).
IDMI is tight-lipped about the whole deal with Junovan (for juvenile osteocarcinoma). I attended the SHM eariler this month in Irvine (near Cortex) and the new CEO was quite bullish on getting the FDA to reverse, although he did not provide details. The results of the pIII trial generated p values suggesting efficacy for Junovan. The scuttlebutt is that the submission to the FDA was missing a form that caused the FDA not to review a portion of the data – the consequence of which the p values were not verified. The FDA turned down IDMI, but apparently gave IDMI an opportunity to set things straight and a re-review will occur with the final decision on August 26.
It is not Junovan with which I am interested and invested in IDMI. The potential Junovan market is micro compared to anyone of the pipeline products and IDMI has one heck-of-a pipeline (most in late-stage pII), all vaccine-base products anyone of which could make IDMI huge. Two of those products, EP-2101 and Uvidem, appear to be effective according to recent presentations of preliminary results at ASCO. The market has not been kind to IDMI where the recent volatility appears to have been entirely related to the fortunes of Junovan and indirectly with DNDN. Current stock price is ~$2.80 and still falling: a PIPE just occurred.
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