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    Homosassa, Fl and Columbia, MD

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  1. There is no way of knowing in advance what restrictions may be in the EUA if it is approved. We will all find out when the authorization is finalized and released. As far as further review, besides and data requirement reporting contained in the EAU, the vaccine at some point in the future will have to undergo a normal BLA (Biologic License Application) submission, review and approval for marketing. A drug in the past where the clinical results in the trials showed such life changing results that the drug, trastuzumab (Herceptin), was allowed to be used
  2. It is not only the advisory panel members that need to review the data. There are also the reviewers in the FDA in various areas (microbiology, toxicology, medical, biomedical engineering, chemistry, etc) that will do a review on their respective area, talk to fellow reviewers if another area may impact on their area, write a review which goes to the team leader for that submission to review and write a summary which includes a recommendation for approval or not. The team leader's information will go up the line to the branch chief and for applications of this signifi
  3. By the way, my first cruise back in the seventies was in Celebrity. It was known as Chandris at that time. Some of the big chances since that time include the loss of the Greek connection (including the fabulous Greek cuisine), no longer paying to reserve a deck chair, and dressing for dinner (formal) every night.
  4. Who is unhappy? We do have a Celebrity cruise booked for April. Final payment is in December. Will we cancel or make final payment and see how the Covid 19 situation plays out is a decision we will have to make. On any case, flexibility is the key (and a sound background in science and clinical research) . As far as any marketing changes, we will see how the changes fit in with our cruising preferences. We started cruising in our twenties and are now in our seventies, so we have passed through all the different age/family/activity dem
  5. Why don't you try the MSC website which will give you specific information on the ship? I am linking the MSC webpage on the Armonia which gives a description of the cabins and a deck plan (where you will find the handicap cabins and their bedding). After reviewing the deck plans, try contacting MSC for specific information as to questions on door sizes. I have traveled with a friend on MSC that uses a scooter and walker and found MSC to be helpful in finding a cabin. https://www.msccruisesusa.com/cruise/ships/msc-armonia
  6. Just a clarification for the FDA Advisory panel role in the approval process. An advisory panel is just that, it only gives "advise" on whether to approve or disapprove a product. FDA can ignore the opinion of the advisory panel and do the opposite (approve or disapprove).
  7. We have sailed on the Armonia and looked forward to sailing her again. We found her an easy ship to navigate around (but the again, I have a good sense of direction and spatial relationships).
  8. The one I had stroke me as an Egg McMuffin that was on a flat triangular bread instead of a muffin.
  9. I tried the one with egg on the Divina. I liked it and had it in the back of my mind as a breakfast option but with all the other choices, I never picked it again.
  10. I believe on the Armonia the problem is not that the buffet is too large, but that the serving area is too small. Hence the use of the two other areas immediately outside the buffet area for additional food .
  11. Good reason for the pineapple and ham pizza appearing only once. It goes against every culinary standard that the pizza chef has to put pineapple and ham on a pizza.
  12. More FYI for the Armonia, The sticky buns are on the starboard side (pizza), on the port side, the hamburger and fries area is the omelet station for breakfast. The free gelato stand is forward of the pool area on the port side.
  13. It may not be that easy to sub contract or license to other manufacturers. Producing vaccines is not as easy as producing capsules or tablets. Facilities must have the equipment and trained personnel to manufacture the vaccine and there are other hurdles such as FDA inspections, approval of the site and testing to show bioavailability/bioequivalence.
  14. True. But the basics remain the same. I wanted to brush up on complement fixation.
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