ADLS Interesting post from another board mention FDA target dates of 7/31.
>>On June 2, an advisory panel voted against the drug's efficacy for
severe cases of community acquired pneumonia. Although they said that
it reached all of its safety endpoints. ADLS' trials were to prove
the drug's effectiveness against mild-to-moderate cases of CAP so that
people could receive treatment before their illness reached a critical
stage (becoming severe) that would require hospitalization. This
advisory panel only makes recommendations to the FDA... the FDA still
has to make up its own mind. Interestingly, ADLS had worked with the
FDA, through CAP drug workshops designed by the FDA, to model their
trials in the first place. At the time, ADLS believed that making a
CAP drug that was meant for mild-to-moderate CAP was, in fact, the
best approach for getting approval. If the FDA votes against
cethromycin a lot of health professionals (doctors, nurses, etc.) will
be very disappointed. There is a great need for this drug and it can
do a lot of good. Although there are always chances that it won't get
approval, it is highly doubtful that it won't at least get partial
approval. The FDA may require additional trial-work to further
demonstrate its efficacy endpoints against severe CAP -- the target
populations from the last trial were specifically for mild-to-moderate
and the numbers that were used by the panel to support their
conclusions on efficacy were unreliable, to say the least. The FDA
knows this and won't make the same mistake. They may require further
trials, or approve it for mild-to-moderate forms of CAP just simply
because of the public need, then request further trial work to see
what can be done to tweak it for severe CAP. The drug can always be
resubmitted, down-the-road, for sever CAP, as well. In my opinion,
its chances of getting approval look very good at the moment. I do
not expect delays on this one. I think that the FDA will state
exactly what they plan to do with cethromycin. I think that the news,
however complicated and unclear at first as it may be, will show to be
very good for the company. Marketing will come.
On Jun 24, 3:20 am, Jack Le <biopharmasto...@gmail.com> wrote:
<<<<<
"Tis surprising to see how rapidly a panic will sometimes run through a country.
...their peculiar advantage is, that they are the touchstones of sincerity and hypocrisy, and bring things and men to light that might otherwise have lain forever undiscove
