Nano Med Tech Back On Analysts' Radar.

Online, February 17, 2010 (Newswire.com) - Little is known about the small, Shanghai-based biomedical science outfit, Nano Med Tech Inc, but over the last year they have repeatedly stirred IPO-type rumblings which are linked to their highly secretive FDA approval trials. The product is highly protected from media scrutiny under the non-disclosure agreements laid down at federal level and also, it appears, by similar gag-type orders which have, to date, been attributed to Nano Med Tech's assumed partnership with a large venture capital outfit.
However, after a prolonged period of quiet with respect to Nano Med Tech's progress through the FDA gateways, news has surfaced this week that Nano Med Tech, and their partners, have benefitted from the position of trialing a product for which there is no current equivalent on the market.
In simple terms, the prediction from the speculators (credited to a source close to the firm in Shanghai, China) is that, due to some terms and definitions in the FDA guidelines, which have drawn previous debate for offering too broad a scope for interpretation, the guidelines to which the Nano Med Tech product is required to adhere to will be somewhat less stringent.
For a new drug to win approval, the FDA does not require it to be better than products already available-only that it be effective (better than nothing) and fairly safe. For high-risk devices, demonstration of safety and efficacy are also required. But for moderate risk devices - a class to which the Nano Med Tech product is expected to belong, only safety and substantial equivalence to a previously marketed device are required. The benefit of a new drug or device must be judged to outweigh the risks. This is all Congress has allowed the FDA to require.
In some cases, the definition of "effective" is narrow and may not address the end results of therapy. A drug that achieves a "surrogate outcome" may be approved if it lowers cholesterol, lowers high blood pressure, or improves heart rhythm-without knowing if it improves life expectancy.
Clearly the FDA definitions leave alot to interpretation. However, certain analysts have cast doubt on the speculative view that federal approval requirements will be loosened for what could effectively be a new class of drug, arguing that such a compound would automatically be classified as high-risk by virtue of its unique, and hence unqualified nature.
In response, it has been noted that, other than Nano Med Tech and the FDA, nobody knows more about the prospects than the elusive, though much talked about, funding party. It is difficult to produce examples of VC's getting behind tomorrows technologies today in this way, suggesting there is sound logic in the argument that they would not have nailed their flag (and their funds) to the mast at such an early stage, were the product not fully expected to realise its touted approval and go-to-market status.
Whatever the actual variables at play, it's clear that the focus on Nano Med Tech has not gone away and that a sizeable chunk of the active speculative community are taking its prospects seriously?