AIMT AIMT

Usually the approval letter goes to the company and FDA publishes it the next day. When it is a blockbuster drug FDA also takes the pride in announcing prior to the company. When Scott Gottlieb was the FDA commissioner he was quick in such announcements. These days it has slowed down. I would think Nestle acquisition is likely to happen next week prior to the approval...

I doubt if the approval will happen this or even next week. FDA may take its full allotted time and approve on the 24th or 27th. The sad part is the stock will bleed during this time.

Hello all!! I am long! Not gonna lie I’m getting antsy! Is there a plan B if we don’t get approval??

I happened to listen to the entire adcom in Sep. Anaphylaxis was a topic of discussion by one Dr., however it was well defended by AIMT CSO. FDA was very supportive at this adcom. My take was they were ready to approve soon. One other discussion was in the REMS and labeling. I believe AIMT will be negotiating with the agency to ensure a safe and effective label, which is potentially taking this long for approval. I am very confident that this approval will occur soon. I have been loading since Sep. Have a healthy position of 6K shares at a good price.

A good opportunity for buyer such as Nestle to acquire AIMT prior to approval so that they pay less. Good for investors as the stock can go higher on both the news ?

$30 coming soon.

Best thing to do is start accumulating

Unbelievable how the stock performed today after all the good news it carried after adcomm. Very interesting!

Added more PM @28.65

I would say FDA would take until Jan to sort the labeling/REMS for this product. The product will be likely approved only on its PDUFA date probably a week or two early. That said since the labeling/REMS would need to be implemented by the firm based on FDA’s request, the product will likely be available in Late Feb early March. But this is still the best alternative therapy. Carrying Epipen should not be an issue as these patients always carry them. However, ~60% efficacious in terms of resistance building is a positive outcome. The company is also working on egg allergies. Generic competition are less likely in such products. The company will grow from here.