PDS Biotechnology Corporation (PDSB) Social Stream
Featured Post From StockTwits About PDSB
$PDSB Looks like we got some answers to the delay.stockystockys, published August 13, 2021
Information was answered between July 22- 29 by the laboratory in the interior of São Paulo, but Anvisa made a second request.
"These latest information has already been analyzed, but considered insufficient, generating a new request for developers to answer technical questions," the agency said.
"We lack the material to do all of this in large quantities, because we made a scaling. We left the bench scale, which is that laboratory scale, we did a first scaling in which we increased the batch size to do the pre tests. clinical, and we made another batch increase to be able to make doses for humans. Every time you change this batch size, you change the resins, the columns and all the materials involved,"
Despite the delay, Helena believes that, if the materials arrive in two weeks, it is still possible to start in September and accelerate the tests, so that they can be concluded by the end of the year.