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iwasadiver

09/14/21 5:13 PM

#402084 RE: IkeEsq #402083

Thank you! This is precisely what so many of us understand. When you invest in a company like this you absolutely have to understand chess and quit thinking like a checkers player.

CrashOverride

09/14/21 5:14 PM

#402085 RE: IkeEsq #402083

Well said.

Impatient shareholders should sell now so I can buy.

VikingInvest

09/14/21 5:51 PM

#402094 RE: IkeEsq #402083

I really don't get it either. I am investing in a company where I know EXACTLY the process they have decided to take and I approve of it. It is not like they haven't told us numerous times what is going to take place. Is it taking longer than I expected? YES. That being said, I am comfortably waiting for the process to play out. I can see how this timeline is not ideal for the hit and run crowd, but I am here through commercialization. Despite having a decent size of shares, I am comfortable, knowing the CEO has a lot more riding on this than I have.

MI Dendream

09/15/21 8:08 AM

#402157 RE: IkeEsq #402083

Ike, Are the not approved to run an Early Access Program in the US? I may be mistaken. That does require FDA approval BTW. It is treated similarly to a study but you can charge patients for cost of goods delivered. If my recollection is correct, patients never needed right to try legislation, they just needed action on an EAP.

If you are referring to legally defined harm, I would defer to your opinion. Certainly, pressure to move EAP forward with study sites does not seem to be happening and would not be expected before data release. CRL can provide all the drug cash paying US patients will need and the experience of running logistics and support would benefit all patients in the immediate post launch period. This two tiered system separates the middle class from the wealthy, however, which doesn’t sit too well for too long. I give them a pass on EAP until Oct 2020 plus a few months. After that, it is helpful to exert pressure.