Biotech Values

[drbio45]

Sarepta will probably announce that they will file the NDA

Almost all companies that have meetings like this say that they were given guidance by the FDA that they can file.

The problem is that the actual transcripts of the meetings are never made public so ninety percent of the time the fda probably says you can file the NDA but that doesn't mean the drug will be approved

Hemispherix has filed many NDA's. Sometimes their NDA's have been approved for filng, but when it comes time for the approval the answer is no.

if they submit a copy of the letter as an exhibit or quote from the letter I will accept it, otherwise I think approval is a long shot.

Glazo's drug has much more data. This drug hasn't been in enough patients for the fda to know if there is some kind of toxicity that hasn't shown up yet.