Oramed starts patient recruitment in Israel for ORMD-0801 clinical trial for patients with T1DM

I can see you have done a lot of research but you clearly do not understand diabetic management. You really missed the boat on understanding short acting, long acting. rapid acting insulin. You need to explain how it is possible to have oral insulin that is not  broken down before it gets in the blood. Are these drugs actually oral hyperglycemics and what is the mechanism of action that they use so they can be compared to drugs on the market.  The statements you made about Mannkind further exposes you lack of understanding about the FDA approval process. Al Mann is an engineer that was hired by NASA shortly after JFK made his famous speech to put a man on the moon by the end of the decade. Mr. Man is responsible for the first implantable pacemaker, the first wearable insulin pump and the cochlear implant, just to name a few of his achievements. He has made billions but only after everyone of these inventions initially failed. Mannkind started almost 20 years ago and when used with the insulin pump is the holy grail of insulin control simulating a normal functioning nondiabetic. I don't have the time this minute to take each point but will do so later. But let me take the first point. The 800,000 page FDA submission. They can not lie about something like that. If it were a lie, every law firm in the country would be lining up to sue them and so would the SEC. There has been over a billion dollars spent in the development of what you call the "eternally-resubmitted Afrezza. "  I know this is Mannkind's first product to market but this is not All Mann's first time to the prom. The FDA wants everything every written about Afrezza and the FDA use to require everything in a certain format and now requires everything be converted but also wants the original data. You mention an FDA panel and if you listened to the ALL the conference calls, most likely an advisory panel will not be necessary. The FDA actually previously approved Afrezza and sent an intra agency memo to employees. An employee immediately purchased the stock in a relative's name. A different FDA employee came forward with a letter, reportedly written by a Hedge Fund manager, that complained they would be breaking their own rules if they approved Afrezza because the safety data was collected on the earlier designed inhaler so the FDA sent out another memo to it's employees and the employee that bought the stock immediately sold his shares before the public was aware of the FDA decision. He obviously was caught and all this information came out in the trial and became public knowledge. All the CRL required Mannkind to do was to do a study showing the two inhalers worked comparably so they could use the safety data from the earlier studies and they did that and actually the FDA sent Mannkind a letter acknowledging they made a complete response to the FDA CRL. Efficacy was never a question in the CRL, Mannkind had previously demonstrated safety and efficacy using the old design and an advisory panel approved Afrezza. But not enough of the data was performed using the new design and so Mannkind had to do additional studies designed and approved with cooperation of the FDA to use the prior data. Incidentally, the newer design inhaler is smaller, cheaper to manufacture and such an engineering success that it delivered the drug to the capillary alveoli so efficiently, Mannkind actually cut the dose in half and that does adjustment necessitated the CRL and the additional studies. One last incidentally, Mannkind manufactured their own very rapid acting insulin, a first in class type of insulin that is active in the blood in 5 minutes, peaks in 30 minutes and is out of the body in 2 hours. A person can use the inhaler after they start eating. Essentially identical to insulin produced by the body. In contrast the fast acting Novolog insulin must be taken prior to meals (a nightmare to do in nursing homes and hospitals while waiting for food from the kitchen)  takes 3 times longer before it is active and 3 times longer to peak and is in the body for up to 5 hours. Because Novolog is in the body so long, life threatening hypoglycemia is a risk that is almost non existent with Afrezza since it is out of the body in 2 hours. That is why diabetics have to continuously eat snacks because the meal time prandial insulin last too long or they risk diabetic ketoacidosis if they don't snack, which also causes significant weight gain so obviously weight gain is not a problem associated with Afrezza. The drugs you mentioned have only completed Phase I trials and if and when they are approved would be making it to market about the time Afrezza will be coming off patent.

opps I meant to post this on seeking alpha