After it failed to secure FDA clearance of its emergency allergy drug, Adamis Pharmaceuticals Corp. (NASDAQ: ADMP) has said it would not give up in the efforts to bring the drug to market. The FDA requested for additional data on Adamis’ compound and the company is getting down on additional tests that would provide it with the data requested by the regulator.
According to Adamis Pharmaceuticals Corp. (NASDAQ: ADMP)’s CEO, Dennis J. Carlo, they are committed continuing working with FDA to ensure that their epinephrine shot gets approved for marketing. Because the FDA has requested more data on two studies of the drug for allergic reactions, Adamis wants to move fast to begin those additional tests before it can resubmit request for clearance of the drug.
In a matter of weeks
CEO Carlo said that a few weeks should be adequate for them to submit to the FDA the protocols for the additional tests on their emergency allergy compound. As soon as they receive feedback from the FDA, Carlo said they will immediately launch the testing. As such, Adamis Pharmaceuticals Corp. (NASDAQ: ADMP) officials anticipate that they will be able to submit to the FDA the additional data requested in the back half of 2016.
Adamis Pharmaceuticals Corp (NASDAQ: ADMP) has confidence about getting it right
The latest setback marks the second time that Adamis has failed to secure regulatory clearance for epinephrine for treating severe allergic reaction. But CEO Carlo said that they are confident that they will meet the FDA requirement when they submit the additional data requested.
No retreat, no surrender
Carlo projects an image of a CEO willing to give everything to a course that will see epinephrine approved for severe allergy indication. Setbacks might come, but he sees the compound inching closer to marketing approval each day data on it is submitted to the FDA.
Adamis Pharmaceuticals Corp (NASDAQ: ADMP)’s epinephrine is a prefilled single dose syringe that is primarily designed to tackle a form of severe allergy called anaphylaxis.